(30 days)
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
NexGen TM Tibial Trays may be used with or without bone cement (biological fixation).
The NexGen Trabecular Metal (TM) Tibial Tray is part of the Zimmer NexGen family of semiconstrained, nonlinked condylar knee prostheses.
Here's a breakdown of the acceptance criteria and the study information for the NexGen ® Trabecular Metal™ Tibial Tray, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Set by Regulations/Industry Standards for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Mechanical properties consistent with predicate device (NexGen Porous, Uncemented Tibial Baseplates, K031061) to ensure safety and effectiveness for intended use. | "Mechanical testing of the subject device demonstrated that it is substantially equivalent to the predicate device." |
| No significant changes in intended use or fundamental scientific technology compared to the predicate device. | "Except for minor modifications, the NexGen TM Tibial Tray is identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology." |
Study Details:
-
Sample size used for the test set and the data provenance:
- No specific sample size for a test set is mentioned. The study primarily relies on mechanical testing for non-clinical performance and a comparison to a predicate device. The document does not describe a clinical study with human subjects for the purpose of primary device clearance, so there is no "test set" in the traditional sense of a clinical trial.
- Data Provenance: The mechanical testing would have been conducted by Zimmer, Inc., likely in a laboratory setting, to compare the physical properties of the new device to the established properties of the predicate. This would be considered retrospective in the sense that the predicate device's performance data already existed.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the study relies on mechanical testing against a predicate device, not on expert adjudication of clinical outcomes for a "test set." The "ground truth" for substantial equivalence rests on the established performance of the predicate device and the physical testing results.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as there was no clinical test set requiring expert adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a total knee prosthesis, and its clearance process did not involve MRMC studies, which are typically relevant for diagnostic imaging AI tools.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (a knee implant), not an algorithm or AI system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's acceptable performance is primarily derived from the established performance and safety of the predicate device (NexGen Porous, Uncemented Tibial Baseplates), coupled with laboratory mechanical testing results proving equivalence. No clinical outcomes data for this specific device were needed for clearance.
-
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device. The mechanical testing results serve as evidence to support the claim of substantial equivalence to the predicate device, whose "ground truth" efficacy and safety would have been established through its own clearance process (likely involving mechanical testing and potentially clinical data if it were a novel device at the time).
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K072160
Summary of Safety and Effectiveness
SEP - 5 2007
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Brandon Hipsher, RACSenior Associate, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605 |
| Date: | August 3, 2007 |
| Trade Name: | NexGen ® Trabecular Metal™ Tibial Tray |
| Common Name: | Total Knee Prosthesis |
| Classification Nameand Reference: | Knee joint patellofemorotibialpolymer/metal/polymer semiconstrained cementedprosthesis21 CFR § 888.3560 |
| Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesis21 CFR § 888.3565 | |
| Predicate Device: | NexGen Porous, Uncemented Tibial Baseplates,manufactured by Zimmer, Inc., K031061, clearedOctober 9, 2003. |
| Device Description: | The NexGen Trabecular Metal (TM) Tibial Tray ispart of the Zimmer NexGen family ofsemiconstrained, nonlinked condylar kneeprostheses. |
| Intended Use: | This device is indicated for patients with severeknee pain and disability due to:- Rheumatoid arthritis, osteoarthritis,traumatic arthritis, polyarthritis.- Collagen disorders, and/or avascularnecrosis of the femoral condyle |
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| - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. | |
|---|---|
| - Moderate valgus, varus, or flexion deformities. | |
| - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. | |
| NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). | |
| Comparison to Predicate Device: | Except for minor modifications, the NexGen TM Tibial Tray is identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. |
| Performance Data (Nonclinical and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Mechanical testing of the subject device demonstrated that it is substantially equivalent to the predicate device. | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. |
. . . . .
:
"
and the comments of the comments of the comments of the comments of
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2007
Zimmer, Inc. % Mr. Brandon Hipsher, RAC Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, IN 46581
Re: K072160 Trade/Device Name: NexGen® Trabecular Metal™ Tibial Tray Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial/metal/metal constrained cemented prothesis Regulatory Class: II Product Code: MBH, JWH Dated: August 31, 2007 Received: September 5, 2007
Dear Mr. Hipsher:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Brandon Hipsher, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Harbara Buenn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
NexGen® Trabecular Metal™ Tibial Tray
Indications for Use:
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
NexGen TM Tibial Trays may be used with or without bone cement (biological fixation).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Bourin
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K072160
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.