For NexGen Augments used with NexGen Knee Systems - Cruciate Retaining (CR), Cruciate Retaining Augmentable (CRA), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS), and Legacy Constrained Condylar Knee (LCCK): 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.

· CR and LPS porous coated femoral and tibial baseplate components may be used cemented biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.

· NexGen Augments that may be used with cemented CR, CRA, PS, and LCCK femoral and tibial baseplate components are indicated for cemented use only.

For NexGen Augments used with NexGen Rotating Hinge Knee System:

This device is indicated for patients with:

Moderate to severe knee instability.
Significant bone loss and/or ligament deficiencies caused by neoplasms, traumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
Valgus, varus, or flexion deformities.
The salvage of previously failed surgical attempts.
This device is intended for cemented use only.

Device Description

The NexGen augments are used with the following NexGen Knee Systems: NexGen Rotating Hinge Knee, NexGen Complete Knee Solution: Cruciate Retaining Augmentable (CRA), Legacy Constrained Condylar (LCCK), Cruciate Retaining (CR), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS). This submission includes tibial and femoral augments of various shapes and sizes. Augments are attached via bone cement or screw to tibial baseplate and femoral components indicated for cemented use only. Use of these augments is optional.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) premarket notification for Zimmer NexGen Knee Solution Tibial and Femoral Augments does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria, as typically seen for AI/ML-driven medical devices.

The document is a clearance letter and a 510(k) summary for a physical medical device (knee implants - augments), not a software or AI/ML device. Therefore, it discusses performance based on non-clinical testing (shelf life, attachment strength, PMMA coated titanium substrate to bone cement properties) and states that clinical data and conclusions were were not needed for this device's clearance.

The questions you've asked (regarding acceptance criteria for device performance in terms of AI metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are specifically relevant to the evaluation of AI/ML software as a medical device (SaMD) or AI-assisted devices. This document does not describe such an evaluation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2015

Zimmer, Incorporated Mr. Mark D. Warner Sr. Specialist. Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K152494

Trade/Device Name: Zimmer® NexGen® Complete Knee Solution Tibial and Femoral Augments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, KRO Dated: August 31, 2015 Received: September 2, 2015

Dear Mr. Warner:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152494

Device Name

Zimmer® NexGen® Complete Knee Solution Tibial and Femoral Augments

Indications for Use (Describe)

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 Augments that may be used with cemented CR, CRA, PS, and LCCK femoral and tibial baseplate components are indicated for cemented use only.

For NexGen Augments used with NexGen Rotating Hinge Knee System:

This device is indicated for patients with:

Moderate to severe knee instability.
Significant bone loss and/or ligament deficiencies caused by neoplasms, traumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
Valgus, varus, or flexion deformities.
The salvage of previously failed surgical attempts.
This device is intended for cemented use only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image features the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized letter "Z" inside it. Below the circle is the word "zimmer" in lowercase blue letters.

	510(k) Summary
Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Mark WarnerSr. Specialist, Regulatory AffairsTelephone: (574) 372-4150Fax: (574) 372-4605
Date:	August 31, 2015
Trade Name:	Zimmer® NexGen® Complete Knee Solution Tibial andFemoral Augments
Common Name:	Prosthesis, Knee, Patellofemorotibial, Semi-constrained,Cemented, Polymer/Metal/Polymer
	Prosthesis, Knee, Femorotibial, Constrained, Cemented,Metal/Polymer
Classification Namesand References:	Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis, 21 CFR 888.3560,JWH
	Knee joint femorotibial metal/polymer constrainedcemented prosthesis, 21 CFR 888.3510, KRO
Classification Panel:	Orthopedics/87
Predicate Device(s):	NexGen Complete Knee Solution Cruciate Retaining(Augmentable) and Legacy Constrained Condylar Knee,manufactured by Zimmer, Inc. (K946150)
	NexGen Complete Knee Solution Rotating Hinge Knee,manufactured by Zimmer, Inc. (K013385)
Purpose and DeviceDescription:	The NexGen augments are used with the followingNexGen Knee Systems:

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NexGen Rotating Hinge Knee NexGen Complete Knee Solution:

· Cruciate Retaining Augmentable (CRA)
Legacy Constrained Condylar (LCCK)
· Cruciate Retaining (CR)
· Posterior Stabilized (PS)
· Legacy Posterior Stabilized (LPS)

This submission includes tibial and femoral augments of various shapes and sizes. Augments are attached via bone cement or screw to tibial baseplate and femoral components indicated for cemented use only. Use of these augments is optional.

For NexGen augments used with NexGen Knee Systems -Cruciate Retaining (CR), Cruciate Retaining augmentable (CRA), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS), and Legacy Constrained Condylar Knee (LCCK):

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.

CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.

NexGen augments that may be used with cemented CR, CRA, PS, LPS, and LCCK femoral and tibial baseplate components are indicated for cemented use only.

Intended Use:

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	For NexGen augments used with NexGen Rotating HingeKnee System:
	This device is indicated for patients with:- Moderate to severe knee instability.- Significant bone loss and/or ligament deficiencies causedby neoplasms, trauma, rheumatoid arthritis, osteoarthritis,traumatic arthritis, polyarthritis, collagen disorders,and/or avascular necrosis of the femoral condyle.- Valgus, varus, or flexion deformities.- The salvage of previously failed surgical attempts.This device is intended for cemented use only.
Comparison to Predicate Device:	NexGen tibial and femoral augments were initially clearedin K946150, K013385. The subject devices includeadditional shapes and sizes of the predicate devices. Theyhave the same intended use, function, and fundamentaltechnology as the predicate devices. The differencebetween the subject and predicate devices do not raise newissues of safety and effectiveness.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:Shelf Life Testing:Accelerated aging testing conducted demonstrated that thesubject NexGen augments have a shelf life of 10 years.
	Performance Testing:Non-clinical testing demonstrated that the subject NexGenaugments have adequate attachment strength to resist jointreaction forces generated during weight-bearing activitiesand that PMMA coated titanium substrate to bone cementdemonstrated an increased maximum shear load comparedto uncoated titanium.
	Clinical Performance and Conclusions:Clinical data and conclusions were not needed for thisdevice.

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.