Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems:
· Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.

· Failed previous surgery where pain, deformity, or dysfunction persists.
· Revision of previously failed hip arthroplasty

The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:

· Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases
· Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, or total hip replacement (THR)
· Acute traumatic fracture of the femoral head or neck
· Avascular necrosis of the femoral head.
· Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
· Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
· Acute traumatic fracture of the femoral head or neck.
· Avascular necrosis of the femoral head.

The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis,
polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
· Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
· Patients with acute femoral neck fractures.

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis,
polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.

· Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
· Patients suffering from disability due to previous fusion.
· Patients with previously failed endoprostheses and/or total hip components in the operative extremity.
· Patients with acute neck fractures.
This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
Noninflammatory degenerative joint disease (NID), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.
· Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
· Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.

• Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

· Revision of previously failed hip arthroplasty

Device Description

Zimmer Hip Joint Replacement Prostheses are hip replacement system components. A femoral stem component is used in conjunction with a femoral head component for replacement of the proximal femur in total hip arthroplasty. Femoral stems are available in different designs, materials, sizes, neck lengths and taper sizes. A taper is incorporated in the design of the stem to interlock it with the femoral head. Femoral head components are available in a variety of sizes and neck lengths for reconstruction of the natural head center of the femur. The purpose of this submission is the addition of MR conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging, or sterilization.

AI/ML Overview

The provided document is a 510(k) premarket notification for Zimmer Hip Joint Replacement devices. The submission focuses on adding MR conditional information to the labeling for existing predicate devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" pertain specifically to the MR Conditional safety of the implants and not to the efficacy of the hip replacements themselves.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with numerical values for MR Conditional testing results. Instead, it states that the devices have been determined to be MR Conditional based on specific testing. The acceptance criteria are implied by adherence to the standard ASTM F2503-13.

Acceptance Criteria (Implied by adherence to standard and FDA clearance)	Reported Device Performance (Summary)
Device meets MR Conditional safety requirements outlined in ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment regarding RF-induced heating, static magnetic field interactions, and image artifact generation.	"The interactions of Zimmer Hip Joint Replacement implants with static and time-varying magnetic fields during Magnetic Resonance Imaging procedures have been evaluated and the subject devices have been 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." "Data and scientific rationalizations to quantify the RF-induced heating, static magnetic field interactions, and image artifact generation of the Zimmer Hip Joint Replacement implants in the 1.5 Tesla (T) and 3.0 T MRI clinically relevant environments have been generated."

Acceptance Criteria (Implied by adherence to standard and FDA clearance)

Reported Device Performance (Summary)

Device meets MR Conditional safety requirements outlined in ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment regarding RF-induced heating, static magnetic field interactions, and image artifact generation.

"The interactions of Zimmer Hip Joint Replacement implants with static and time-varying magnetic fields during Magnetic Resonance Imaging procedures have been evaluated and the subject devices have been 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." "Data and scientific rationalizations to quantify the RF-induced heating, static magnetic field interactions, and image artifact generation of the Zimmer Hip Joint Replacement implants in the 1.5 Tesla (T) and 3.0 T MRI clinically relevant environments have been generated."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size of the devices tested for MR compatibility. It refers to "Zimmer Hip Joint Replacement implants" in general. The data provenance is not mentioned, but given the nature of the testing (evaluating physical interactions with magnetic fields), it would likely be laboratory-generated data rather than patient data. The country of origin of the data is not specified, but the applicant is Zimmer GmbH, Switzerland.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For MR compatibility testing, the "ground truth" is typically established by physical measurements and adherence to engineering standards, rather than expert consensus on diagnostic images. The expertise would lie in the engineers and physicists conducting the testing and interpreting the results according to ASTM F2503-13.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers evaluate medical images or data. This document describes a technical evaluation of device interaction with MRI fields. Therefore, an adjudication method in this sense is not applicable or described. The "adjudication" is essentially the determination of compliance with the ASTM F2503-13 standard.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is about the MR compatibility of hip implants, not about diagnostic AI or human reader performance.

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

This question is not applicable. The device is a physical medical implant, not an algorithm. The testing performed was related to the physical properties of the implant in an MRI environment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for MR Conditional testing is based on physical measurements and adherence to the technical requirements and thresholds defined in the ASTM F2503-13 standard. This includes measurements of RF-induced heating, static magnetic field interactions (e.g., deflection force, torque), and image artifact size.

8. The sample size for the training set

This question is not applicable. This is not an AI/algorithm-based device that requires a training set. The study is a technical evaluation of physical implants.

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

This question is not applicable, as there is no training set for this type of device and study.

Summary

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April 10, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Zimmer GmbH Anne-Kathrin Born Regulatory Affairs Senior Specialist Sulzer Allee 6 Winterthur. 8404 Ch

Re: K200112

Trade/Device Name: Zimmer Hip Joint Replacement Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, LPH, KWZ, JDI, KWL, KWY, LWJ, MEH Dated: February 6, 2020 Received: February 12, 2020

Dear Anne-Kathrin Born:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K200112

Device Name

Alloclassic® Zweymüller® SL / SL Offset Femoral Stems

Indications for Use (Describe)

Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems:

· Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.

· Failed previous surgery where pain, deformity, or dysfunction persists.
· Revision of previously failed hip arthroplasty

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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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510(k) Number (if known) K200112

Device Name Avenir® Cemented Hip Stem

Indications for Use (Describe)

The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:

· Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases
· Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, or total hip replacement (THR)
· Acute traumatic fracture of the femoral head or neck
· Avascular necrosis of the femoral head.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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510(k) Number (if known) K200112

Device Name Avenir® Müller Stem

Indications for Use (Describe)

· Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
· Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
· Acute traumatic fracture of the femoral head or neck.
· Avascular necrosis of the femoral head.

Avenir® Müller Stems are for cementless 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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510(k) Number (if known) K200112

Device Name BIOLOX® delta Ceramic Femoral Head

Indications for Use (Describe)

The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:

· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis,

polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.

· Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.

· Patients with acute femoral neck fractures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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510(k) Number (if known) K200112

Device Name

BIOLOX® OPTION Ceramic Femoral Head System

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:

· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis,

polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.

· Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
· Patients suffering from disability due to previous fusion.
· Patients with previously failed endoprostheses and/or total hip components in the operative extremity.
· Patients with acute neck fractures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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510(k) Number (if known) K200112

Device Name Fitmore® Hip Stem

Indications for Use (Describe)
--------------------------------

This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
Noninflammatory degenerative joint disease (NID), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.
· Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
· Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.

This stem is for uncemented 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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510(k) Number (if known) K200112

Device Name Wagner Cone Prosthesis

• Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.

· Failed previous surgery where pain, deformity, or dysfunction persists.

· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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510(k) Number (if known) K200112

Device Name Wagner SL Revision Stem Lateral

Indications for Use (Describe)

· Revision of previously failed hip arthroplasty

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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Image /page/10/Picture/0 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a white "Z" inside it, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is also blue, and the logo is clean and modern.

510(k) Summary

Sponsor:	Zimmer GmbHSulzerallee 8, P.O. Box8404 Winterthur, Switzerland
Contact Person:	Anne-Kathrin Born, Regulatory AffairsTelephone: +41 58 854 86 19Fax: + 41 52 244 86 58
Date:	April 02, 2020
Trade Name:	Zimmer Hip Joint Replacement
Common Name:	Hip Prosthesis
Classification Name:	LZO - Prosthesis, hip, semi-constrained, metal/ceramic/polymer,cemented or non-porous, uncemented (21 CFR §888.3353).LPH - Prosthesis, hip, semi-constrained, metal/polymer, porousuncemented (21 CFR §888.3358).KWZ - Prosthesis, hip, constrained, cemented or uncemented,metal/polymer (21 CFR §888.3310).JDI - Prosthesis, hip, semi-constrained, metal/polymer, cemented(21 CFR §888.3350).KWL - Prosthesis, hip, hemi-, femoral, metal (21 CFR §888.3360).KWY - Prosthesis, hip, hemi-, femoral, metal/polymer, cemented oruncemented (21 CFR §888.3390).LWJ - Prosthesis, hip, semi-constrained, metal/polymer,uncemented (21 CFR §888.3360).MEH - Prosthesis, Hip, Semi-Constrained, Uncemented,Metal/Polymer, Non-Porous, Calcium Phosphate (21 CFR§888.3353).
Predicate Devices:	Wagner SL Revision Stem Lateral, manufactured by ZimmerGmbH, K191781, cleared August 06, 2019Wagner Cone Prosthesis System, manufactured by ZimmerGmbH, K191781, cleared August 06, 2019Biolox Delta Ceramic Femoral Heads, manufactured by ZimmerGmbH, K192416, cleared October 01, 2019Biolox Option Ceramic Femoral Head System, manufactured byZimmer GmbH, K192416, cleared October 01, 2019Fitmore® Hip Stem, manufactured by Zimmer GmbH, K192236,cleared November 5, 2019

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Image /page/11/Picture/0 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is also in blue, matching the color of the circle and "Z" symbol. The logo appears to be clean and modern, representing the company's brand identity.

	Avenir® Cemented Hip Stem, manufactured by Zimmer GmbH, K193030, cleared December 6, 2019
	Avenir® Müller Stem, manufactured by Zimmer GmbH, K193030, cleared December 6, 2019
	Alloclassic® Zweymüller® SL Femoral Stem, manufactured by Zimmer GmbH, K193050, cleared December 26, 2019
	Alloclassic® Zweymüller® SL Offset Femoral Stem, manufactured by Zimmer GmbH, K193050, cleared December 26, 2019
Device Description:	Zimmer Hip Joint Replacement Prostheses are hip replacement system components. A femoral stem component is used in conjunction with a femoral head component for replacement of the proximal femur in total hip arthroplasty. Femoral stems are available in different designs, materials, sizes, neck lengths and taper sizes. A taper is incorporated in the design of the stem to interlock it with the femoral head. Femoral head components are available in a variety of sizes and neck lengths for reconstruction of the natural head center of the femur. The purpose of this submission is the addition of MR conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging, or sterilization.
Indications for Use:	Wagner Cone Prosthesis are indicated for: Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.Failed previous surgery where pain, deformity, or dysfunction persists.Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
	Wagner SL Revision Stem Lateral is indicated for: Revision of previously failed hip arthroplasty.
	The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur

femur.

Patients with congenital hip dysplasia, protrusio acetabuli, .

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Image /page/12/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is also in blue, matching the color of the circle and the "Z" symbol.

or slipped capital femoral epiphysis.

. Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
. Patients with acute femoral neck fractures.

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:

Patients suffering from severe hip pain and disability due to . rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
o Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
. Patients suffering from disability due to previous fusion.
Patients with previously failed endoprostheses and/or total . hip components in the operative extremity.
. Patients with acute neck fractures.

The Fitmore® Hip Stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:

Noninflammatory degenerative joint disease (NIDJD), e. . g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.
. Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
Optional use in revision: in some medical conditions (e. g., o early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.
This stem is for uncemented use only.

Avenir® Müller Stem is intended for:

o Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases.
. Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists.
. Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
. Acute traumatic fracture of the femoral head or neck.
. Avascular necrosis of the femoral head.

Avenir® Müller Stems are for cementless use only.

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Image /page/13/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is also in blue, matching the color of the circle and the "Z" symbol.

The Avenir® Cemented Hip Stem is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:

Advanced wear of the joint due to degenerative, post-. traumatic, or rheumatic diseases
. Failed previous hip surgery including ioint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR)
. Acute traumatic fracture of the femoral head or neck
o Avascular necrosis of the femoral head.

Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems are indicated for:

. Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.q., rheumatoid arthritis.
. Failed previous surgery where pain, deformity, or dysfunction persists.
. Revision of previously failed hip arthroplasty.

Comparison to Predicate Device: The subject devices have the same intended use and are substantially equivalent to the legally marketed predicated devices. Performance Data (Nonclinical Non-Clinical Performance and Conclusions: and/or Clinical): The interactions of Zimmer Hip Joint Replacement implants with static and time varying magnetic fields during Magnetic Resonance Imaging procedures have been evaluated and the subject devices have been 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. Data and scientific rationalizations to quantify the

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Conclusion: The subject devices have the same intended use and similar indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using the same materials and processes as the predicate devices. Except for the modifications described in this submission the

subject devices are identical to the predicate devices, and the performance data and analyses demonstrate that:

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Image /page/14/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The color of the text is a dark gray or blue, matching the color of the "Z" symbol.

any differences do not raise new questions of safety and ● effectiveness as established with performance testing; and
. the subject devices are at least as safe and effective as the legally marketed predicate devices

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.