How effective is the U.S. Food and Drug Administration (FDA) in assuring safety and effectiveness of shoulder arthroplasty implants?

New joint replacement systems and implants are cleared for clinical use by the Food and Drug Administration (FDA) by what is known as the 510(k) mechanism.

510(k) clearance does not require testing of safety and efficacy in clinical trials (see Shoulder Arthroplasty Device Clearance: An Ancestral Network Analysis). Instead 510(k) clearance requires evidence of “substantial equivalence” to a predicate device, i.e. one that has previously been cleared by the FDA. 

Companies use the 510(k) premarket notification pathway for expedient approval of arthroplasty. With the passage of the 21st Century Cures Act, a piece of legislation reducing the rigor and amount of clinical testing required before device clearance, the 510(k) pathway has became further streamlined.

The number of shoulder implants approved by the 510(k) process is rising exponentially (see Is there evidence that the outcomes of primary anatomic and reverse shoulder arthroplasty are getting better?)



No fewer than twenty-nine new shoulder devices having received 510(k) premarket FDA approval over the 12-month period from 2020 – 2021.

Unfortunately, devices cleared through the 510(k) process are 11.5 times more likely to be recalled than devices approved via the more stringent Premarket Approval (PMA) process (see Analysis of FDA-Approved Orthopaedic Devices and Their Recalls). PMA approval is based on a determination by FDA that there is sufficient valid scientific evidence based on formal clinical trials to assure that the device is safe and effective.

Recalls of devices cleared by the 510(k) process typically occur years after the introduction of the device to clinical practice and after hundreds or thousands have been implanted into patients. Consider, for example, the ASR Acetabular & Resurfacing System which was recalled 6 years after being introduced into the market, after 90,000 had been implanted, and after 30% had been revised (see Out of joint: The story of the ASR).

Similarly, for three elbow implants, the lag between introduction to the market and recall ranged from 4 to 16 years, even though there were earlier reports of failure in the FDA's Manufacturer and User Facility Device Experience (MAUDE) data base (see Timely recognition of total elbow and radial head arthroplasty adverse events: an analysis of reports to the US Food and Drug Administration and Analysis of 4063 complications of shoulder arthroplasty reported to the US Food and Drug Administration from 2012 to 2016)





The authors of Shoulder Arthroplasty Device Clearance: An Ancestral Network Analysis sought to evaluate the FDA clearance of shoulder arthroplasty components by examining the interconnected ancestral network of shoulder arthroplasty devices and determining equivalency ties to devices that were subsequently recalled by the FDA because of design-related issues of relevance to patient safety.

They reviewed the FDA 510(k) database to identify all legally marketed shoulder arthroplasty devices from 5/28/1976 to 7/1/2021. Direct predicate information obtained via clearance summary documents associated with each device was used to generate an ancestral genealogy network for all shoulder arthroplasty devices cleared between 7/1/2020 and 7/1/2021. FDA design recalls were analyzed, and the number of descendent devices was calculated for each recalled device.

Their evaluation of all 476 shoulder devices cleared since 1976 identified between 0 and 313 descendent devices for each.

Of the 476 FDA cleared shoulder arthroplasty devices, 130 (27.3%) were linked to at least one predicate device that was subsequently recalled for issues with device design. Furthermore among 29 of the most-recently cleared devices (7/1/2020 – 7/1/2021), 16 (55.2%) were linked to predicate devices that have subsequently been withdrawn from the market due to design related failures. During this time interval no devices were cleared by the more vigorous PMA pathway.

80 of the devices (16.8%) cleared by the 510(k) pathway have since been recalled, of which 10 recalls were directly related to implant design issues (5 shoulder implant systems, 4 humeral components, and 1 glenoid component.) Of the ten devices recalled for device design, the most influential by number of ancestral descendants was K052906 (Zimmer Trabecular Metal Reverse Shoulder System) that had served as an ancestral predicate for 110 descendent devices.

One of the devices, (K080642 - Biomet Comprehensive Reverse Shoulder) was cleared by the FDA in 2008 and recalled in August 2017 due to higher than anticipated rates of implant breakage. K080642 - Biomet Comprehensive Reverse Shoulder served as an ancestral predicate for 67 descendant devices as shown in the figure below which indicates all descendants (Key: Red = recalled, yellow = direct predicate was recalled, green = not recalled and does not have a direct predicate that was recalled).



In 2011, the Institute of Medicine held a workshop that recommended replacement of the 510(k)-clearance process and implement in its place a regulatory premarket and postmarket regulatory framework to provide “a reasonable assurance of safety and effectiveness throughout the device life cycle.” In Congress, legislation to amend the 510(k)- approval process – the Safety of Untested and New Devices Act of 2012 – was introduced but failed to receive a vote on the floor.

Questions regarding the effectiveness of the FDA clearance process for orthopaedic devices have surfaced in the lay press. In 2018 the New York Times published, Can Your Hip Replacement Kill You?
This article tells the story of how orthopaedic implants can get 'cleared' by the FDA for use in patients without rigorous studies of their safety or effectiveness. The author states that the public "assumes that the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all."

Orthopaedic surgeons should read the related book from cover to cover:

Comment: As orthopaedic surgeons, we are frequently presented with new implants that have just arrived on the marketplace, most of which have been 'cleared' by the 510(k) process because they are stated to be 'substantially equivalent' to a previously marketed device. However, these new devices cannot be 'completely equivalent' to implants that are currently available (otherwise they could not be patented and successfully marketed). The gap between 'substantial' and 'complete' equivalency allows for unexpected results and unanticipated complications as well as new technical challenges and learning curves in using the new system. Thus, when considering a new device, we need to ask "in what ways is the new thing different than what is currently in common use?" and "what are the potential adverse outcomes that might result from these differences" (see Assessing the Value to the Patient of New Technologies in Anatomic Total Shoulder Arthroplasty).

Finally, it seems that we should push for a better definition of "substantial equivalency'. Different bearing surfaces, different articular surface shapes, different materials, different fixation systems, and different degrees of modularity do not seem to be 'substantially equivalent'. Patient safety would seem to be served by a closer examination of systems that are not, in fact, substantially equivalent.

See this related post on device failure and FDA clearance.

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Here are some videos that are of shoulder interest

Shoulder arthritis - what you need to know (see this link).

How to x-ray the shoulder (see this link).

The ream and run procedure (see this link).

The total shoulder arthroplasty (see this link).

The cuff tear arthropathy arthroplasty (see this link).

The reverse total shoulder arthroplasty (see this link).

The smooth and move procedure for irreparable rotator cuff tears (see this link).

Shoulder rehabilitation exercises (see this link).

"Can Your Hip Replacement Kill You?" The book every orthopaedic patient and every orthopedic surgeon must read.

Can Your Hip Replacement Kill You?

The New York Times published this article last month. It tells the story of how orthopaedic implants can get 'cleared' by the FDA for use in patients without rigorous studies of their safety or effectiveness. But rather than just reading the article, we strongly recommend that you read the book from cover to cover:

The author tells the story of an orthopaedic surgeon who had a colleague treat his hip arthritis using a metal-on-metal hip.

Five years after his surgery he underwent a second surgery to have the device replaced. When his surgeon opened his hip, what he found a condition called "metallosis" in which metal debris had damaged local muscle and bone. In addition there was evidence that metal ions from the hip were affecting the function of his heart and brain. Over 9,000 patients had complications related to these implants. The device was recalled by the company in 2010 (see this link).

Of course, "recalling" a defective device implanted in thousands of people is a much bigger deal than recalling a car with a defective airbag (see this link).

Should all patients with 'recalled' devices have them removed? Who should pay for the costs and cover the risks of such a revision surgery?

The author points out (and we quote) that the public "assumes that the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.

Although the standard for approval of a new drug usually calls for two randomized, controlled clinical trials, the standard for many medical devices is no standard at all. Since medical devices didn’t come under regulatory control by the F.D.A. until 1976, the agency simply grandfathered in all devices that were already on the market under a provision known as 510(k), which allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is “substantially equivalent” to an existing device.

In addition to the 510(k) pathway, medical device companies can avoid clinical testing for the highest risk devices through the supplement pathway by telling the F.D.A. they made a minor change to a previously approved device."

Comment: As orthopaedic surgeons, we are frequently presented with new implants that have just arrived on the marketplace, most of which have been 'cleared' by the 510(k) process because they are stated to be 'substantially equivalent' to a previously marketed device. However, these new devices cannot be 'completely equivalent' to implants that are currently available (otherwise they could not be patented and successfully marketed). The gap between 'substantial' and 'complete' equivalency allows for unexpected results and unanticipated complications as well as new technical challenges in implanting the new system.

A recent article, Analysis of FDA-Approved Orthopaedic Devices and Their Recalls, (see this link), points out that the recall rate was 17.8% for 510(k)-cleared devices. Those authors concluded that:  "given that 510(k)-cleared devices were 11.5 times more likely to be recalled than PMA-approved devices, it is concerning that most orthopaedic devices are cleared through the 510(k) process with limited clinical trials data."

Thus, when considering a new device, we need to ask "how does this differ from what is currently in common use?" and "what are the potential adverse outcomes that might result from these differences".

Finally, it seems that we should push for a better definition of "substantial equivalency'. Different bearing surfaces, different articular surface shapes, different materials, different fixation systems, and different degrees of modularity do not seem to us to be 'substantially equivalent'. Patient safety would seem to be served by a closer examination of systems that are not, in fact, substantially equivalent.

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You can support cutting edge shoulder research that is leading to better care for patients with shoulder problems, click on this link.

Follow on twitter: https://twitter.com/shoulderarth

Follow on facebook: click on this link

Follow on facebook: https://www.facebook.com/frederick.matsen

Follow on LinkedIn: https://www.linkedin.com/in/rick-matsen-88b1a8133/

Here are some videos that are of shoulder interest

Shoulder arthritis - what you need to know (see this link).

How to x-ray the shoulder (see this link).

The ream and run procedure (see this link).

The total shoulder arthroplasty (see this link).

The cuff tear arthropathy arthroplasty (see this link).

The reverse total shoulder arthroplasty (see this link).

The smooth and move procedure for irreparable rotator cuff tears (see this link).

Shoulder rehabilitation exercises (see this link).

How safe are FDA-cleared joint implants?

The 510(k) Ancestry of a Metal-on-Metal Hip Implant

This article from the New England Journal of Medicine contains an important perspective on the FDA clearance process for orthopaedic devices. The following paragraphs are critical reading for those concerned about implant safety:

"Many medical devices that pose great safety risks to Americans, including metal-on-metal hip implants, currently enter the U.S. market through a Food and Drug Administration (FDA) regulatory pathway that is not intended for evaluating safety and effectiveness. This pathway, called the 510(k) process, instead involves evaluation of “substantial equivalence” to previously cleared devices, many of which have never been assessed for safety and effectiveness and some of which are no longer in use because of poor clinical performance.

The Medical Device Amendments of 1976 created three classes of devices: class I included low-risk devices, such as toothbrushes; class II contained moderate-risk devices, such as infusion pumps; and class III included high-risk devices and those awaiting proper classification, such as metal-on-metal hip implants. These classes roughly corresponded to the level of premarketing review required. Thus, class I and II devices underwent review for substantial equivalence to devices already on the market, also called preamendment devices (although subsequent legislation granted exemptions). Class III devices were meant to undergo the more rigorous premarket approval (PMA), the only pathway that requires clinical data. However, class III devices were allowed to receive review for substantial equivalence temporarily, until the FDA down-classified these devices or promulgated regulations requiring PMA. Congress had always intended class III devices to undergo PMA, and in 1990, it directed the agency to establish a schedule to finish the transition to PMAs for all devices that were to remain in class III.

As of December 19, 2012, however, the FDA still had not completed this transition to PMA for high-risk devices, although it had stated its intention to clear proposed rules for all remaining class III preamendment devices by December 31, 2012. Currently, 19 different types of class III devices, including metal-on-metal hip implants, are allowed to reach patients through 510(k) clearance. Because of this loophole, companies that market these devices are often legally able to obtain clearance without demonstrating safety and effectiveness through clinical studies, but by claiming substantial equivalence to earlier “predicate devices” — or pieces of those devices — which may also have been found substantially equivalent to even earlier devices, and so on, all the way back to preamendment devices. Because many predicates have never been assessed for safety and effectiveness, an FDA finding of substantial equivalence does not mean that a new device is safe and effective; it means only that the device is deemed no less safe and no less effective than a predicate.1 Even voluntarily recalled devices can serve as predicates, as long as the FDA did not formally remove these devices from the market or a court did not find them adulterated or misbranded.

One prominent type of class III device that remains eligible for 510(k) clearance is metal-on-metal hip implants, such as the DePuy ASR XL Acetabular Cup System, which received FDA clearance in July 2008 without a clinical study. The Australian Orthopaedic Association National Joint Replacement Registry initially reported in September 2008 that this device required revision surgery at a high rate, and in 2010 the National Joint Registry (NJR) for England and Wales reported a 5-year revision rate of approximately 13%, which was more than four times the registry's reported 5-year revision rate for all hip-replacement prostheses combined. DePuy voluntarily recalled the ASR XL in Australia in 2009, citing “declining demand” as a reason, and then worldwide in 2010 because of the high revision rate reported by the NJR.

Using FDA documents obtained from the agency's database and Freedom of Information Office, we traced the ancestry of the ASR XL back more than five decades, through a total of 95 different devices (including femoral stems), including 15 different femoral heads and sleeves and 52 different acetabular components (see figure).

The point here is that the 510(k) clearance process does not provide assurance that a device is either safe or effective. It only states that it is "substantially equivalent" to a prior legally marketed device (even if that device had been been withdrawn from the market by the company because of safety concerns (see this link).

By contrast, premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III is the most scientifically rigorous classification of medical devices and encompasses most of the orthopedic implants on the market today (see this link).

It is worthwhile understanding the difference between these two FDA mechanisms.

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The reader may also be interested in these posts:

Healing through joint replacement

Supporting progress in shoulder surgery

Consultation for those who live a distance away from Seattle.

Click here to see the new Shoulder Arthritis Book.

Click here to see the new Rotator Cuff Book

Information about shoulder exercises can be found at this link.

Use the "Search" box to the right to find other topics of interest to you.

You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

See from which cities our patients come.

See the countries from which our readers come on this post.

Failed reverse total shoulder arthroplasty - who's responsible?

Mechanics and complications of reverse shoulder arthroplasty: morse taper failure analysis and prospective rectification

These authors report a metallurgic analysis of the fractured humeral tray of a reverse total shoulder humeral component using Scanning Electron Microscopy (SEM) and Electron Dispersion Spectroscopy (EDS). The atraumatic failure occurred four years ofter the arthroplasty by dissociation of the taper from the humeral tray at the weld, leaving the Morse taper embedded in the humeral stem while the tray floated freely in the patient’s shoulder.

SEM further confirmed the jagged edges noted grossly at the weld fracture site, both suggesting failure due to torsional forces.

EDS detected elevated levels of carbon and oxygen at the fracture site on the taper. In order to determine the origin of the high levels of C and O, it was considered that in titanium alloys, C and O are used as stabilizers that help raise the temperature at which titanium can be cast. Since the presence of stabilizers reduces ductility and fatigue strength, all interstitial elements are removed after casting. Considering this, the presence of C and O suggests that not all of the interstitials were removed during the manufacturing process, resulting in decreased fatigue strength. In other words residual C and O in the taper lowered the metal implant’s integrity, leading to torsional cracking at the weld junction of the humeral tray and the taper. The elevated levels of C and O measured at fracture sites on both the tray and the taper suggest poor quality filler metal or failure to remove all interstitial elements after casting. The authors suggest that the system was undersized, considering the actions the shoulder is expected to be able to carry out. The short length of the Morse taper, thinness of the humeral tray, weaker metal system, and small surface area of the weld site between the taper and tray all posed probable causes of failure. The result was decreased fatigue strength and overall toughness, leading to mechanical failure.

This design has been recalled after a number of similar failures.

Comment: New shoulder implants are being introduced to the marketplace each year. Many of these have a modular design, which necessitates a junction between different component elements. Each of these junctions represents a site for potential corrosion and fatigue failure.

While it is tempting for surgeons to assume that "FDA approval" means that the device is safe, we must recognize that this approval usually does not include a careful trial of these implants in human subjects before they are released for general use. As a result, delayed failures - as represented by this report - may not become evident until after the implant has been out in general use for years. When design-related failures occur, years may pass before enough data are collected for a product recall.

Thus the surgeon needs to become a careful consumer, knowledgeable about metallurgy, fatigue and corrosion. 

A recent article discusses the surgeon's responsibility for the use of new technologies:

Introduction of New Technologies in Orthopaedic Surgery. 

The bullet points are

➢ The introduction of new devices, biologics, and combination products to the orthopaedic marketplace is increasing rapidly.

➢ The majority of these new technologies obtain clearance to market by demonstrating substantial equivalence to a predicate (previously approved device) according to the U.S. Food and Drug Administration (FDA) 510(k) process.

➢ Surgeons play a critical role in the introduction of new technologies to patients and must take a leadership role in promoting safe, efficacious, appropriate, and cost-effective care, especially for operative procedures.

➢ Surgeons should monitor and document their patients’ clinical outcomes and adverse events when using new technology, to ensure that the new technology is performing as desired.

This fits right in with a prior post: 

Analysis of FDA-Approved Orthopaedic Devices and Their Recalls.

These authors note that there are two paths by which medical devices, such as shoulder implants, can obtain approval for use by the U.S. Food and Drug Administration (FDA).  The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be "substantially equivalent" to existing devices.

They hypothesized that because 510(k) approval was less stringent, it would be more commonly used on one hand and devices approved by this mechanism would be more likely to be recalled.

They searched for the following: PMA and 510(k) clearances for orthopaedics and non-orthopaedic specialties from 1992 to 2012. They also searched for all device recall events from 2002 to 2012. For the top-twenty recall companies, they calculated the odds ratio that compares the likelihood of recall for 510(k)-approved devices with that for PMA-approved devices.

While non-orthopaedic devices are increasingly approved by PMA:

Orthopaedic devices continue to be approved principally by 510(k):

The type of approval process is strongly related to the frequency of recall:from 2002 to 2012, the percentage of recalled devices was 17.8% for 510(k)-cleared devices and 1.6% for PMA-approved devices. 

They conclude that 510(k)-cleared devices were 11.5 times more likely to be recalled than PMA-approved devices; therefore is concerning that most orthopaedic devices are cleared through the 510(k) process with limited clinical trials data.

These data suggest that the 510(k) process, being easier and less expensive, is being used for devices that are not, in fact, "substantially equivalent to existing devices. " If they were "substantially equivalent", the recall rate discrepancy would not be what it is. It may be time to re-look at what it takes to qualify for 510(k) approval.

When we see data, such as that shown below from the AOA registry, it makes us wonder how "new" implants come to market, and which ones were claimed to be "substantially equivalent".

The question also arises, "with the dramatic increase in the number of new implants that are being introduced are patients getting better results?" See this recent post.

Is there evidence that the outcomes of primary anatomic and reverse shoulder arthroplasty are getting better?

These authors noted that the number of shoulder arthroplasty implants and related devices approved by the FDA are improving exponentially with time.

These new devices increase the cost of shoulder arthroplasty surgery because of their associated development, FDA approval and marketing costs as well as the learning curves and uncertainty of outcomes in comparison to devices that have been in use for longer periods of time.

The authors sought to use published evidence from studies published from 1990 to 2015 to answer the question, "are the patient-reported outcomes and re-operation rates better in reports of more recently performed anatomic (TSA) and reverse (RSA) total shoulder arthroplasties?" The difficulty in answering such a question lies in the fact that the study methods and patient cohorts differ among different reports, confounding attempts to compare the results.

Inclusion criteria for this investigation were met by 42 TSA studies with a mean (± SD) of 116±159 (range, 20–705) patients per study with an average follow-up of 5±3 years, 42±21% males with average age 66±5 years. Inclusion criteria were met by 37 RSA studies with 56±32 (20–174) patients per study with an average follow-up of 4±5 years, 34±15% males with average age 72±5 years.

In order to compare studies that used different outcome scales (ASES, SST, Constant, Dash, SANE, etc), the authors normalized each scale to a 0 (worst) to 100 (best) outcome score.  They considered the outcome in terms of the final post-operative score as well as the percent of maximal possible improvement (%MPI).  As shown in the figure below, the particular outcome scale used in the different publications had a major effect on the normalized outcome score for shoulder arthroplasty. For TSA, the mean normalized post-operative scores were ≥80% for reports using the WOOS, UCLA, Penn, and SANE scales and <65% using the DASH or Constant scales. For RSA, the mean normalized postoperative scores were ≥70% for the Oxford, ASES and VAS Pain scales and ≤60% for the SANE and UCLA scales. For both TSA and RSA the Simple Shoulder Test was at the median.

The diagnosis for which the arthroplasty was performed presented another confounder in the comparison among studies.  For reports of TSA, osteoarthritis (OA) was most common diagnosis (73% for an average study), but the percentage of patients with this diagnosis varied greatly from study to study (0–100%). For reports of RSA, the most common diagnosis was cuff tear arthropathy (CTA) (48% for an average study) but, again, the percentage of patients with this diagnosis varied greatly from study to study (0-100%). For both types of arthroplasty, the diagnosis had a significant effect on the outcome as shown in the figure below. For TSA the results were worse in those studies of rheumatoid arthritis (RA) and cuff tear arthropathy (CTA). Clinical outcomes for RSA were worse in studies of post-traumatic arthritis (PTA).

Over the two decades of this study, there were marginally significantly better clinical outcomes in reports of more recently performed TSAs (p = 0.048). The plots below show the mean outcome score adjusted for outcome scale and diagnosis by median year of surgery.

For RSA the trend showed no significant improvement.

Neither the revision rate for TSA (Coefficient -0.48, 95% CI from -1.35 to 0.39, p= 0.3) or the revision rate for RSA (Coefficient -0.84, 95% CI (from -2.87 to 1.19, p= 0.4) were significantly lower in studies reporting more recently performed procedures.

It appears that better evidence will be necessary to demonstrate that newer implants and techniques are yielding improved clinical outcomes for patients with glenohumeral arthritis.

The authors suggest that future studies reporting the results of shoulder arthroplasty should include an appendix containing a set of basic data elements for each patient so that meaningful comparisons can be facilitated. Such a data set should include for each patient the age, sex, diagnosis, the scale used to document the presurgical and postoperative patient self-assessed shoulder comfort and function, and date and reason for any reoperation. While this minimal data set will not capture the full set of potential confounders— such as the degree of shoulder stiffness, the condition of the rotator cuff, radiographic pathoanatomy and the effect of surgical team volume and experience—this degree of standardization will enable a more robust comparison of the outcomes for individual patients treated over time with different therapeutic approaches, so that we can learn whether newer implants and techniques contribute added value to the patient with glenohumeral arthritis.

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Healing through joint replacement

Supporting progress in shoulder surgery

Consultation for those who live a distance away from Seattle.

Click here to see the new Shoulder Arthritis Book

Click here to see the new Rotator Cuff Book

You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

See from which cities our patients come.

See the countries from which our readers come on this post.

Use the "Search" box to the right to find other topics of interest to you.

Total joint FDA approvals and recalls

Analysis of FDA-Approved Orthopaedic Devices and Their Recalls.

These authors note that there are two paths by which medical devices, such as shoulder implants, can obtain approval for use by the U.S. Food and Drug Administration (FDA).  The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be "substantially equivalent" to existing devices.

They hypothesized that because 510(k) approval was less stringent, it would be more commonly used on one hand and devices approved by this mechanism would be more likely to be recalled.

They searched for the following: PMA and 510(k) clearances for orthopaedics and non-orthopaedic specialties from 1992 to 2012. They also searched for all device recall events from 2002 to 2012. For the top-twenty recall companies, they calculated the odds ratio that compares the likelihood of recall for 510(k)-approved devices with that for PMA-approved devices.

While non-orthopaedic devices are increasingly approved by PMA:

Orthopaedic devices continue to be approved principally by 510(k):

The type of approval process is strongly related to the frequency of recall:from 2002 to 2012, the percentage of recalled devices was 17.8% for 510(k)-cleared devices and 1.6% for PMA-approved devices. 

They conclude that 510(k)-cleared devices were 11.5 times more likely to be recalled than PMA-approved devices; therefore is concerning that most orthopaedic devices are cleared through the 510(k) process with limited clinical trials data.

Comment: These data suggest that the 510(k) process, being easier and less expensive, is being used for devices that are not, in fact, "substantially equivalent to existing devices. " If they were "substantially equivalent", the recall rate discrepancy would not be what it is. It may be time to re-look at what it takes to qualify for 510(k) approval.

When we see data, such as that shown below from the AOA registry, it makes us wonder how "new" implants come to market, and which ones were claimed to be "substantially equivalent".

A recent article discusses the surgeon's responsibility for the use of new technologies:

Introduction of New Technologies in Orthopaedic Surgery. The bullet points are

➢ The introduction of new devices, biologics, and combination products to the orthopaedic marketplace is increasing rapidly.


➢ The majority of these new technologies obtain clearance to market by demonstrating substantial equivalence to a predicate (previously approved device) according to the U.S. Food and Drug Administration (FDA) 510(k) process.


➢ Surgeons play a critical role in the introduction of new technologies to patients and must take a leadership role in promoting safe, efficacious, appropriate, and cost-effective care, especially for operative procedures.


➢ Surgeons should monitor and document their patients’ clinical outcomes and adverse events when using new technology, to ensure that the new technology is performing as desired.

===

Consultation for those who live a distance away from Seattle.

Use the "Search" box to the right to find other topics of interest to you.

You may be interested in some of our most visited web pages including:shoulder arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

See from which cities our patients come.

See the countries from which our readers come on this post.