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.

This device is intended for cemented use only.

Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90prefix 17 or 20mm Prolong™ Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

Device Description

The NexGen Knee GSF Femoral Components include both LPS-Flex GSF and CR-Flex GSF versions and are part of the Zimmer Flex-series of semiconstrained, nonlinked, condylar knee prostheses that are designed to have a maximum active flexion of 155 degrees. The GSF designation indicates that the design of the femoral component has been modified slightly to address specific anatomic features of the distal femur that can be seen in both male and female patients, but are more typical of a female patient.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NexGen® Knee Gender Solutions Female (GSF) Femoral Components:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Demonstrates substantial equivalence to predicate devices (NexGen LPS-Flex knee, K991581; NexGen CR-Flex femoral component, K023211).	Mechanical testing and Finite Element Analysis of the NexGen Knee GSF Femoral Components indicate that they are substantially equivalent to the predicate devices.
Functional Equivalence	Except for modifications to address specific anatomic features typical of a female patient, these components are identical to their respective predicate device.	The GSF designation indicates that the design of the femoral component has been modified slightly to address specific anatomic features of the distal femur that can be seen in both male and female patients, but are more typical of a female patient.
Manufacturing/Sterilization	Packaged and sterilized using the same materials and processes as predicate devices.	The device is packaged and sterilized using the same materials and processes.
Clinical Performance	(No specific clinical acceptance criteria stated for this device, as clinical data was deemed not needed.)	Clinical data and conclusions were not needed for this device.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. The submission explicitly states "Clinical data and conclusions were not needed for this device." The primary evaluation relied on non-clinical testing (mechanical testing and Finite Element Analysis) and comparison to predicate devices, rather than a clinical test set with human subjects.
Data Provenance: Not applicable for a human subject test set. The data provenance for the non-clinical mechanical testing and Finite Element Analysis would be internal laboratory data generated by Zimmer, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No human subject test set was used, and therefore no ground truth established by experts in this context.

4. Adjudication method for the test set

Not applicable. No human subject test set was used.

5. 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

Not applicable. This device is a total knee prosthesis, not an AI-assisted diagnostic tool or imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm or software. The "standalone" performance here refers to the mechanical and analytical performance of the physical device components, which was assessed through non-clinical testing.

7. The type of ground truth used

The implicit "ground truth" for the performance evaluation of this medical device is the established performance and safety characteristics of its predicate devices (NexGen LPS-Flex Knee and NexGen CR-Flex femoral component). The device is deemed safe and effective if it can demonstrate substantial equivalence to these legally marketed predicates through mechanical testing and component analysis.

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI algorithm that requires a training set. The "training" in product development would refer to engineering design, CAD modeling, and material selection based on established bio-mechanical principles and previous device designs.

9. How the ground truth for the training set was established

Not applicable. As noted above, this isn't an AI device with a training set. The design was informed by the established anatomical features and performance of prior generations of knee prostheses, particularly those with modifications for "female" anatomical characteristics. The "ground truth" for its design would be anatomical data, biomechanical principles, and the performance history of existing devices.

Summary

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K160370 page 174

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Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Contact Person:	Stephen McKelvey, MA, RAC Manager, Corporate Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 372-4605
Date:	February 10, 2006
Trade Name:	NexGen ® Knee Gender Solutions Female (GSF) Femoral Components
Common Name:	Total Knee Prosthesis
Classification Name and Reference:	Knee joint, patellofemorotibial, metal/polymer, semi-constrained, cemented prosthesis 21 CFR § 888.3560
Predicate Devices:	NexGen LPS-Flex knee, manufactured by Zimmer, K991581, cleared July 30, 1999 and the NexGen CR-Flex femoral component, manufactured by Zimmer, K023211, cleared October 17, 2002
Device Description:	The NexGen Knee GSF Femoral Components include both LPS-Flex GSF and CR-Flex GSF versions and are part of the Zimmer Flex-series of semiconstrained, nonlinked, condylar knee prostheses that are designed to have a maximum active flexion of 155 degrees. The GSF designation indicates that the design of the femoral component has been modified slightly to address specific anatomic features of the distal femur that can be seen in both male and female patients, but are more typical of a female patient.
Intended 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

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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.

This device is intended for cemented use only.

Except for modifications to address specific anatomic features typical of a female patient, these components are identical to their respective predicate device. The device is packaged and

Performance Data (Nonclinical and/or Clinical):

Comparison to Predicate Device:

Non-Clinical Performance and Conclusions:

sterilized using the same materials and processes.

Mechanical testing and Finite Element Analysis of the NexGen Knee GSF Femoral Components indicate that they are substantially equivalent to the predicate devices.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

a Julia

Zimmer, Inc. c/o Mr. Stephen McKelvey, MA, RAC Manager, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K060370 Trade/Device Name: NexGen® Knee Gender Solutions Female (GSF) Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint, patellofemorotibial, polymer/metal/polymer, semiconstrained, cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: February 10, 2006 Received: February 13, 2006

Dear Mr. McKelvey:

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

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Page 2 - Mr. Stephen McKelvey, MA, RAC

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. 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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark McMillan

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® Knee Gender Solutions Female (GSF) Femoral Components

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.

This device is intended for cemented use only.

Specific uses with CR-Flex GSF or LPS-Flex GSF femorals:

Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong™ Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
- The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use
No
(21 CFR 807 Subpart C) /アビ

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulm Lemuta

Division of General, Restorati and Neurological Devic

Page 1 of 1

510(k) Number Koio'370

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.