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.

Specific indications for various components and systems are also listed.

Device Description

The purpose of this submission is the addition of MR Conditional labeling to the Instructions for Use for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization. The subject devices are intended for use in knee arthroplasty.

AI/ML Overview

The provided text is related to the Zimmer Knee Joint Replacement Prostheses MR Labeling and details its indications for use and a summary of performance data related to MR Conditional labeling. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond MR Conditional labeling.

The document states:

The purpose of the submission is the addition of MR Conditional labeling to the Instructions for Use for predicate devices.
The addition of MR labeling does not impact indications, materials, design features or dimensions, packaging or sterilization.
Clinical data was not provided for the subject devices.
Non-clinical tests were performed to establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment.

Therefore, I cannot fulfill all parts of your request as the provided text lacks the detailed information regarding a broad set of acceptance criteria and a study proving the device meets them beyond MR safety.

However, I can extract information related to the MR Conditional testing.

Information on MR Conditional Testing (the only "performance data" provided):

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (for MR Conditional Labeling)	Reported Device Performance (as per non-clinical tests)
RF-induced heating (ASTM F2182-11a)	Testing performed (results not detailed, but implied to meet "MR Conditional" status)
Image Artifact (ASTM F2119-07)	Testing performed (results not detailed, but implied to meet "MR Conditional" status)
Magnetic Displacement (ASTM F2052-14)	Testing performed (results not detailed, but implied to meet "MR Conditional" status)
Nonpyrogenicity	Testing performed

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

Sample Size: Not specified for the MR tests. The testing refers to "implants," implying samples of the knee joint replacement prostheses.
Data Provenance: Not explicitly stated, but the tests refer to ASTM standards, which are international standards for materials testing. The testing was performed by "Zimmer." The overall submission is for regulatory clearance in the United States (FDA). The study is retrospective as it refers to testing already performed to support the 510(k) submission.

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

Not applicable. For these non-clinical engineering-based MR safety tests, "ground truth" is established by adherence to the specified ASTM test method standards and the physical properties of the materials, rather than expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation (e.g., image reading). These non-clinical tests rely on instrumental measurements and adherence to standard protocols.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. The document explicitly states "Clinical data was not provided for the subject devices." These are non-clinical hardware tests for MR compatibility.

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

Not applicable. This device is a physical knee prosthesis, not an algorithm. The MR conditional tests evaluate the physical interaction of the device with an MR environment.

7. The type of ground truth used:

The "ground truth" for these specific MR tests is defined by the physical measurement criteria and thresholds stipulated in the cited ASTM standards (F2182-11a, F2119-07, F2052-14) for determining "MR Conditional" status, and the standard for nonpyrogenicity. It relates to the inherent material and design properties of the implanted device.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set."

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

Not applicable. As above, no training set exists for this type of device.

In summary, the provided document details the indications for use for various Zimmer Knee Joint Replacement Prostheses and the fact that non-clinical tests were conducted to demonstrate MR Conditional safety and compatibility, allowing for appropriate MR labeling. It does not provide performance data or acceptance criteria in the context of clinical efficacy or diagnostic accuracy, as it explicitly states no clinical data was provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 29, 2018

Zimmer, Inc. Jason Heckaman Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K173057

Trade/Device Name: Zimmer Knee Joint Replacement Prostheses MR Labeling Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, KRO, KRR Dated: February 28, 2018 Received: March 1, 2018

Dear Mr. Heckaman:

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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Mr. Jason Heckaman

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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)

Device Name

Zimmer Knee Joint Replacement Prostheses MR Labeling - NexGen® CR, PS, CRA, LPS and LCCK Knee

Indications for Use (Describe)

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 patellectorly.
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, LPS, and LCCK femoral and tibial baseplate components are indicated 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Indications for Use

510(k) Number (if known)

Device Name

Zimmer Knee Joint Replacement Prostheses MR Labeling - NexGen® All-Polyethylene Patella

Indications for Use (Describe)

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 indicated for cemented use only.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Indications for Use

510(k) Number (if known)

Device Name

Zimmer Knee Joint Replacement Prostheses MR Labeling - NexGen® Tibial Components/Modular Tibial Plates

Indications for Use (Describe)

This device is indicated for patients with severe knee pain and disability due to:

Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders, and/or avasculart 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). NexGen MIS Tibial Plates and Keels are intended for cemented use only

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Indications for Use

510(k) Number (if known)

Device Name

Zimmer Knee Joint Replacement Prostheses MR Labeling - NexGen® CR-Flex Fixed Bearing Knee

Indications for Use (Describe)

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-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.

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

Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
The CR-Flex femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm 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 femoral, when used with the 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.

Specific Uses with NexGen LPS or LCCK femorals:

The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees.
The usage of the LCCK femoral is the same as the LPS with the exception that femoral boss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other than that provided by the Next Gen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces.

|×| Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{10}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

Zimmer Knee Joint Replacement Prostheses MR Labeling - NexGen® CR-Flex Gender Solutions Female (GSF)

Indications for Use (Describe)

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 patellectorly.
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.

The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only.

The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented (biological fixation).

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 17 or 20 mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent 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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{12}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

Zimmer Knee Joint Replacement Prostheses MR Labeling - Zimmer Gender Solutions Patello-Femoral Joint (PFJ)

Indications for Use (Describe)

Osteoarthritis, traumatic arthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).
History of patellar dislocation or patella fracture.
Dysplasia-induced degeneration.

This device is intended for cemented use only.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{14}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

Zimmer Knee Joint Replacement Prostheses MR Labeling - NexGen® Rotating Hinge Knee

Indications for Use (Describe)

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{16}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

Zimmer Knee Joint Replacement Prostheses MR Labeling - Natural-Knee System

Indications for Use (Describe)

The Natural-Knee System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented use in skeletally mature individuals with intact medialeral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IID).

The Natural-Knee primary components without CST Porous Coating and all revision components are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (I.D), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary components are used, the medial and collateral ligaments must be intact.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{18}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

Zimmer Knee Joint Replacement Prostheses MR Labeling - Natural-Knee II System

Indications for Use (Describe)

The Natural-Knee II System with Cancellous-Structured Titanium (CST) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IID).

The Natural-Knee II primary components without CST Porous Coating, all posterior stabilized and revision components, the N-K II Constrained Knee System, the modular cemented tibial baseplate, and revision fluted stem are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NDDD) or Inflammatory Joint Disease (ID), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact.

The Natural-Knee II Durasul polyethylene components are indicons of noninflammatory degenerative joint disease (NDD), e.g., avasular necrosis, ostecarthritis, and inflammatory degenerative joint disease (ID), e.g., theumatoid arthrits; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and reviously failed knee arthroplasty. These devices are intended for cemented use only in the United States.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{20}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

Zimmer Knee Joint Replacement Prostheses MR Labeling - Natural-Knee® II System Domed All-Poly Patella

Indications for Use (Describe)

This device is indicated for:

Patient conditions of noninflammatory degenerative joint disease (NDJD), e.g., avascular necross, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
Correctable valgus-varus deformity and moderate flexion contracture.
Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
Revision of previously failed knee arthroplasty.

This device is intended for cemented use only.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{22}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

Zimmer Knee Joint Replacement Prostheses MR Labeling - Gender Solutions Natural-Knee® Flex System

Indications for Use (Describe)

Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

Components without CST porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDID) or Inflammatory Joint Disease (IID), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.

The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen Trabecular Metal™ CR Monoblock, 90-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{24}------------------------------------------------

510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the subject Zimmer Knee Joint Replacement Prostheses MR Labeling 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708Establishment Registration Number: 1822565
Contact Person:	Jason HeckamanManager, Regulatory AffairsTelephone: (574-371-8313)jason.heckaman@zimmerbiomet.com
Date:	September 27, 2017
Subject Device:	Trade Name: Zimmer Knee Joint Replacement Prostheses MR LabelingCommon Name: Knee ProsthesisClassification Name: JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (21 CFR 888.3560)MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (21 CFR 888.3565)KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer (21 CFR 888.3510)KRR – Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer (21 CFR 888.3540)
Predicate Device(s):	Zimmer, Inc.K872379 Install/Burstein II Modular Total KneeK892800 MG II Porous Total Knee SystemK933785 NexGen Knee SystemK946150 Cruciate Retaining (Augmentable) and Constrained Condylar KneeK951185 NexGen Complete Knee Solution 9mm

{25}------------------------------------------------

	Articular Surface
K960279	NexGen Complete Knee Solution LegacyPosterior Stabilized/Constrained CondylarKnee Femoral Components/ArticularSurfaces
K963148	NexGen Complete Knee Solution
K991581	NexGen Complete Knee Solution LegacyPosterior Stabilized; LPS-Flex Fixed BearingFemoral and Articular Surface
K003910	NexGen Complete Knee Solution Cross-Linked Polyethylene Cruciate RetainingArticular Surface Components
K023211	NexGen Complete Knee Solution CruciateRetaining-Flex Femoral Components
K031061	NexGen Porous, Uncemented Femoral andTibial Baseplate Components
K041100	NexGen Porous HA/TCP UncementedFemoral and Tibial Baseplate Components
K043101	NexGen Complete Knee Solution MIS TibialComponents Locking Screw and StemExtensions
K042271	NexGen Complete Knee Solution LPS-FlexProlong Highly Cross-linked PolyethyleneArticular Surfaces
K052879	NexGen Complete Knee Solution MISModular Tibial Plates and Keels
K060370	NexGen Knee Gender Solutions Female(GSF) Femoral Components
K062768	NexGen Complete Knee Solution LegacyPosterior Stabilized Flex Fixed Bearing andTitanium Ti-6AL-4V Alloy Femoral
K072160	NexGen Trabecular Metal Tibial Tray
K072281	NexGen Prolong All Poly Patella
K072619	NexGen Complete Knee Solution LPS-FlexGender Solutions Female Porous FemoralComponents
K070695	Zimmer Patella Femoral Joint Prosthesis
K013385	NexGen Complete Knee Solution RotatingHinge Knee
K152494	Zimmer NexGen Complete Knee SolutionTibial and Femoral Augments
K931651	Natural-Knee Congruent Tibial Insert withScrew
K935789	Posterior Stabilized Apollo Knee System
K936159	Natural-Knee II System
K970498	Natural-Knee II Revision Femoral Spacer

K972501	Apollo Revision Constrained Knee System
K973412	Natural-Knee II Constrained Knee System
K982903	Sulzer Orthopedics Fluted Stems
K983153	Natural-Knee II Posterior StabilizedCondylar Knee Tibial Inserts
K002335	Natural-Knee II System Durasul Tibial Insertand Durasul All Poly Patella
K013031	Most Options System
K023528	Natural-Knee II Cemented Modular TibialBaseplate
K031183	Tibial Spacer for the Natural-Knee IICemented Modular Tibial Baseplate
K070214	Gender Solutions Natural-Knee Flex System

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Summary of Technological Characteristics:

{27}------------------------------------------------

Indications for Use:

NexGen® CR. PS, CRA, LPS and LCCK Knee

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.

NexGen® All-Polvethvlene Patella

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 indicated for cemented use only.

NexGen® Tibial Components/Modular Tibial Plates

This device is indicated for patients with severe knee pain and disability due to:

Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. -
Collagen disorders, and/or avasculart 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). NexGen MIS Tibial Plates and Keels are intended for cemented use only

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NexGen® CR-Flex and LPS-Flex Fixed Bearing Knee

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, dvsfunction 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-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.

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

Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
The CR-Flex femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm 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 femoral, when used with the 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.

Specific Uses with NexGen LPS or LCCK femorals:

The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees.
The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces.

NexGen® CR-Flex and LPS-Flex Gender Solutions Female (GSF), Knee Femoral Components

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.

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-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.
The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only.

The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation).

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 14 mm or 90-prefix 17 or 20 mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent 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.

Zimmer Gender Solutions Patello-Femoral Joint (PFJ)

Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).
History of patellar dislocation or patella fracture. -
-Dysplasia-induced degeneration.

This device is intended for cemented use only.

NexGen® Rotating Hinge Knee

This device is indicated for patients with:

Moderate to severe knee instability. -
Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, 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.

Natural-Knee System

The Natural-Knee System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and

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lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

The Natural-Knee primary components without CSTi Porous Coating and all revision components are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (JJD). correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary components are used, the medial and collateral ligaments must be intact.

Natural-Knee II System

The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

The Natural-Knee II primary components without CSTi Porous Coating, all posterior stabilized and revision components, the N-K II Constrained Knee System, the modular cemented tibial baseplate, and the revision stem and revision fluted stem are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact.

The Natural-Knee II Durasul polyethylene components are indicated for patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., theumatoid arthritis; correctable valgusvarus deformity and moderate flexion contracture: those patients with failed previous surgerv where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. These devices are intended for cemented use only in the United States.

Natural-Knee®/Natural-Knee® II System Domed All-Poly Patella

This device is indicated for:

Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., । avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
-Correctable valgus-varus deformity and moderate flexion contracture.
Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
Revision of previously failed knee arthroplasty. -

This device is intended for cemented use only.

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Gender Solutions Natural-Knee® Flex System

Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.

The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen CR-Flex Mobile*, NexGen UC-Flex Mobile*, NexGen Trabecular Metal™ CR Monoblock, 90prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Summarv of Performance Data

. Non-Clinical Tests:

Zimmer has performed non-clinical Magnetic Resonance Imaging (MRI) studies on implants which are determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Tests included the following:

RF-induced heating (ASTM F2182-11a) ●
Image Artifact (ASTM F2119-07) ●
Magnetic Displacement (ASTM 2052-14) .

Testing has been performed to establish product nonpyrogenicity.

● Clinical Tests:

Clinical data was not provided for the subject devices.

Non-clinical tests provided in this Traditional 510(k) establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The subject devices are substantially equivalent to the legally marketed predicated devices.

Substantial Equivalence Conclusion

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.