Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis: disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonumon of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The femoral stem is for cementless use only.

Device Description

The Zimmer M/L Taper Hip Prosthesis is a modular, titanium alloy femoral stem designed to replace the proximal femur in total hip arthroplasty. It is flat, collarless and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge shaped prosthesis is designed for cementless use and is circumferentially coated with titanium alloy plasma spray over the proximal body region. A subset of the subject devices are coated with Calcicoat hydroxyapatite tricalcium phosphate coating (HA/TCP) over the coating.

AI/ML Overview

The provided text is a 510(k) summary for the Zimmer M/L Taper Hip Prosthesis, which describes its indications for use, technological characteristics, and a summary of performance data. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the detailed elements requested in your prompt.

Therefore, many of the requested elements (e.g., specific acceptance criteria, reported device performance metrics against those criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not present in this document.

This submission relies on non-clinical tests (performance testing, fatigue testing, range of motion testing) and states that clinical test data is not provided. The purpose is to show that the modified device is substantially equivalent to existing, legally marketed predicate devices, implying that if the predicates met their safety and effectiveness requirements, this device, being substantially equivalent, also meets them.

Here's a breakdown of what can be extracted or inferred, and what is explicitly not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from non-clinical tests)	Reported Device Performance
Equivalence to legally marketed devices (functional)	Performance testing showed equivalence to legally marketed devices.
Compatibility and safe/effective use with acquired devices	Fatigue testing and range of motion testing conducted to show compatibility and safe and effective use.
Non-inferiority in fatigue properties	Fatigue testing was conducted. (Specific metrics not provided)
Acceptable range of motion	Range of motion testing was conducted. (Specific metrics not provided)

Note: The document does not provide specific quantitative acceptance criteria (e.g., "fatigue strength must exceed X MPa") or detailed performance metrics (e.g., "fatigue strength was Y MPa"). It broadly states that tests were completed to "determine equivalence" and "show compatibility and safe and effective use."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not specified for any of the non-clinical tests.
Data Provenance: Not specified, but likely from in-house laboratory testing given it's non-clinical. No mention of country of origin or retrospective/prospective nature as this is not a clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. For non-clinical, mechanical tests, "ground truth" is typically established by engineering standards and measurement techniques, not human expert consensus.

4. Adjudication Method for the Test Set:

Not Applicable. This is not a clinical or imaging study requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states: "Clinical test data is not provided for the subject device." Therefore, no MRMC study was performed or reported here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not Applicable. This is a physical medical device (hip prosthesis), not an algorithm or AI system.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be engineering specifications, material properties, and mechanical performance standards, measured through established laboratory methods.

8. Sample Size for the Training Set:

Not Applicable. This is a physical device, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It reports on non-clinical engineering tests to show the new device's performance aligns with legally marketed predicate devices. It does not contain the detailed clinical study information or AI algorithm validation data that your prompt is designed to elicit.

Summary

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February 28, 2020

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

Zimmer, Inc. Caleb Barylski Specialist, Regulatory Affairs 1800 W. Center Street Warsaw, Indiana 46580

Re: K192660

Trade/Device Name: Zimmer M/L Taper Hip Prosthesis 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, MEH Dated: January 29, 2020 Received: January 30, 2020

Dear Caleb Barylski:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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,

Vesa Vuniqi, MS 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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Indications for Use

510(k) Number (if known) K192660

Device Name Zimmer M/L Taper Hip Prosthesis

Indications for Use (Describe)

The femoral stem is 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)

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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 VerSys Cemented Revision/Calcar 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 September 13, 2019.

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708Establishment Registration Number: 1822565
Contact Person:	Caleb BarylskiRegulatory Affairs SpecialistTelephone: (574) 371-0250
Date:	27 February 2020
Subject Device:	Trade Name: Zimmer M/L Taper Hip ProsthesisCommon Name: Hip Prosthesis
	Classification Name:• LZO - Prosthesis, Hip, Semi-Constrained,Metal/Ceramic/Polymer, Cemented or Non-Porous,Uncemented (21 CFR 888.3353 Hip jointmetal/ceramic/polymer semi-constrained cemented onnonporous uncemented prosthesis)• MEH - Prosthesis, Hip, Semi-Constrained,Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate (21 CFR 888.3353 Hip jointmetal/ceramic/polymer semi-constrained cemented onnonporous uncemented prosthesis)
Predicate Device(s):	K032726	ZIMMER M/LTAPER HIPPROSTHESIS,7711 SERIES	Zimmer, Inc
	K042337	ZIMMER M/LTAPER HIPPROSTHESISWITHCALCICOATCERAMICCOATING	Zimmer, Inc
	K060040	ZIMMER M/L	Zimmer, Inc

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Device Description The Zimmer M/L Taper Hip Prosthesis is a modular, titanium alloy femoral stem designed to replace the proximal femur in total hip arthroplasty. It is flat, collarless and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge shaped prosthesis is designed for cementless use and is circumferentially coated with titanium alloy plasma spray over the proximal body region. A subset of the subject devices are coated with Calcicoat hydroxyapatite tricalcium phosphate coating (HA/TCP) over the coating. Indications for Use: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis; disability due to previous fusion: previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip: elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected. The femoral stem is for cementless use only. Summary of Technological The rationale for substantial equivalence is based on Characteristics: consideration of the following characteristics: Intended Use: Identical ● Indications for Use: Identical ● Materials: Substantially Equivalent ● ● Design Features: Substantially Equivalent . Sterilization: Identical

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Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests:

Performance Evaluation Performance testing o was completed on the Zimmer M/L Taper Hip Prosthesis line extensions to determine equivalence to legally marketed devices.
Compatibility Fatigue testing and range of O motion testing was conducted to show compatibility and safe and effective use with acquired devices.

Clinical Tests:

o Clinical test data is not provided for the subject device.
Substantial Equivalence Conclusion

The data presented in this submission demonstrate that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices perform in a substantially equivalent manner to 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.