· Failed previous hip surgery including joint reconstruction (osteotomy), arthroplasty or total hip replacement (THR).
· Acute traumatic fracture of the femoral head or neck.
· Avascular necrosis of the femoral head.

Avenir Complete Hip System is for cementless use only.

Device Description

The purpose of this 510(k) premarket notification is to introduce two Size 0 Coxa Vara Avenir Complete™ Hip System femoral stems; one with a collar and one without a collar. The stems are manufactured from a forged titanium alloy Ti-6Al-4V and feature a wedge-shaped design with a proximal-to-distal taper and reduced distal geometry. The Coxa Vara offset provides a 126.5° neck angle. Below the highly polished femoral neck region, the surface is gritblasted and plasma sprayed with commercially pure titanium (CP-Ti) and hydroxyapatite (HA) coating. The stems are designed for cementless implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection. The stems are provided sterile and are for single-use only.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device and thus the provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical trial report or a post-market surveillance study would.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets acceptance criteria in the context of a clinical performance study with specific endpoints and statistical measures. Substantial equivalence is established through comparison of intended use, indications for use, technological characteristics, and performance data (primarily non-clinical in this case).

However, I can extract the information relevant to what you've asked, focusing on the performance data presented to support substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As specific "acceptance criteria" are not explicitly defined in terms of sensitivity, specificity, or other clinical performance metrics in this document, the table below will summarize the comparative performance claims made regarding the proposed device in relation to its predicate and reference devices, and how these claims support "substantial equivalence." The "acceptance criteria" for a 510(k) typically align with demonstrating that the new device is "at least as safe and effective" as the predicate.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Mechanical Performance: - Distal Stem Fatigue Strength equivalent to predicate/reference device	Proposed device determined to have distal stem fatigue strength equivalent to the legally marketed reference device (K120030).
Mechanical Performance: - Proximal Stem Fatigue Performance not a "new worst-case" compared to predicate device	Proposed device not a new worst-case for proximal stem fatigue testing compared to the previously evaluated predicate Avenir Complete™ Hip System (K182048).
Material Properties: - Ti/HA Coating Characteristics similar to predicate	Ti/HA Coating Characterization Evaluation was performed (details not provided, but implies similarity as part of overall SE reasoning).
Biocompatibility/Safety: - Corrosion Fatigue performance acceptable	Corrosion Fatigue Evaluation was performed (details not provided, but implies acceptable performance for SE).
Functionality: - Range of Motion compatible with intended use	Range of Motion Analysis was performed (details not provided, but implies compatibility for SE).
Assembly/Fixation: - Pull-Off Strength adequate for intended use	Pull-Off Strength Evaluation was performed (details not provided, but implies adequacy for SE).
Imaging Compatibility: - MRI Compatibility for diagnostic purposes	Magnetic Resonance Imaging Compatibility (MRI) testing was performed (details not provided, but implies compatibility for SE).

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

Sample Size for Test Set: The document indicates that non-clinical performance testing and engineering evaluations were conducted. While specific sample sizes for each test (e.g., number of stems tested for fatigue) are not explicitly stated in this summary, it refers to "fatigue testing," "pull-off strength evaluation," etc. These are typically performed on a statistically relevant number of samples for mechanical testing, but the exact numbers are not in this public summary.
Data Provenance: The data is generated from non-clinical laboratory testing and engineering evaluations. There is no mention of country of origin for this testing, which is typical for such submissions. This is retrospective in the sense that the testing was performed before the submission for clearance.

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

This question is not applicable as the ground truth here is based on engineering and physical measurements from non-clinical testing, not expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as above. No human adjudication is involved in determining the results of mechanical fatigue tests or material characterization.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission explicitly states: "Clinical data and conclusions were not needed for this device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical hip implant system, not an algorithm or AI-driven software device.

7. The Type of Ground Truth Used

The "ground truth" for the performance data presented is based on laboratory measurements and engineering analyses derived from physical testing (e.g., force, cycles to failure, material composition analyses). It is not based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.

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

This question is not applicable for the same reason as above.

Summary

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December 18, 2019

Zimmer, Inc. % Neha Sreenath Senior Specialist, Regulatory Affairs Zimmer GmbH Sulzerallee 8 WINTERTHUR 8404 SWITZERLAND

Re: K192189

Trade/Device Name: Avenir Complete Hip System, Size 0 Coxa Vara 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, KWY, KWZ, LWJ Dated: December 4, 2019 Received: December 5, 2019

Dear Neha Sreenath:

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

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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 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192189

Device Name

Avenir Complete™ Hip System, Size 0 Coxa Vara

Indications for Use (Describe)

Avenir Complete Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions:

· Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.

· Failed previous hip surgery including joint reconstruction (osteotomy), arthroplasty or total hip replacement (THR).
· Acute traumatic fracture of the femoral head or neck.
· Avascular necrosis of the femoral head.

Avenir Complete Hip System 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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K192189

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 Avenir Complete™ Hip System 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:	Neha SreenathSenior Specialist, Regulatory AffairsTelephone: +41 58 854 88 14Email: Neha.Sreenath@zimmerbiomet.com
Date:	August 09, 2019
Subject Device:	Trade Name: Avenir Complete™ Hip System, Size 0 CoxaVaraCommon Name: Hip Prosthesis
Classification Name:	LZO - Prosthesis, Hip, Semi-Constrained,Metal/Ceramic/Polymer, Cemented or Non-Porous,Uncemented (21 CFR §888.3353).MEH - Prosthesis, Hip, Semi-Constrained, Uncemented,Metal/Polymer, Non-Porous, Calcium Phosphate (21 CFR§888.3353).KWZ - Prosthesis, Hip, Constrained, Cemented orUncemented, Metal/Polymer (21 CFR §888.3310).KWY - Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer,Cemented or Uncemented (21 CFR §888.3390).LWJ - Prosthesis, Hip, Semi-Constrained, Metal/Polymer,Uncemented (21 CFR §888.3360).
Legally Marketed PredicateDevice to which SubstantialEquivalence is claimed:	K182048(cleared12/07/2018)	Avenir Complete™Hip System	Zimmer Inc.
Legally Marketed ReferenceDevice used to supportSubstantial Equivalence:	K120030(cleared08/17/2012)	Taperloc CompleteSize 4mm and XR123°	BiometManufacturingCorp

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Purpose and Device Description:

Intended Use and Indications for Use:

Summary of Technological Characteristics:

Avenir Complete™ Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions:

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

Avenir Complete™ Hip System is for cementless use only.

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: Identical to the predicate device. ●
Indications for Use: Identical to the predicate device. .
Design Features: The proposed and predicate devices . incorporate the same design features and fundamental scientific technology. Both stems mate with a variety of femoral heads and adapters equipped with 12/14 tapered necks. The stem length, femoral offset, and collared geometry are features existing in the predicate device.
Fixation Method: Identical to the predicate device.
. Materials: The proposed and predicate devices are manufactured from Ti-6A1-4V alloy and plasma

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sprayed with commercially pure titanium (CP-Ti) and hydroxyapatite (HA) using the same manufacturing processes.

. Sterilization Method: Identical to the predicate device.

Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Testing:

Non-clinical performance testing and engineering evaluations were conducted to verify that the performance of the proposed device is adequate for anticipated in-vivo use. Non-clinical testing carried out on the proposed device include distal stem fatigue testing and proximal stem fatigue testing. Testing demonstrated that the proposed device is not a new worst-case for proximal stem fatigue testing but presents a greater challenge to distal stem fatigue testing than the previously evaluated predicate Avenir Complete™ Hip System range (K182048). Nevertheless, the proposed device was determined to have a distal stem fatigue strength equivalent to the legally marketed reference device (K120030).

The following non-clinical testing is provided in this 510(k) to support substantial equivalence determination of the proposed device to the predicate device in terms of safety and performance:

1. Finite Element Analysis to identify the worst-case stem size for the mechanical fatigue testing
1. Distal Stem Fatigue Testing
1. Proximal Stem Fatigue Testing
1. Range of Motion Analysis
1. Pull-Off Strength Evaluation
1. Corrosion Fatigue Evaluation
1. Ti/HA Coating Characterization Evaluation
1. Magnetic Resonance Imaging Compatibility (MRI)

Clinical Testing:

Clinical data and conclusions were not needed for this device.

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Substantial Equivalence Conclusion

The proposed device has the same intended use and indications for use as the predicate device. The proposed device uses the same operating principle, incorporates the same design and materials, and is manufactured and sterilized using the same manufacturing processes as the predicate device. Technological characteristics of the proposed device are the same as the predicate device and similar to the reference device, and the performance data and analyses demonstrate that:

any differences do not raise new questions of safety . and effectiveness as established with performance testing; and
. the proposed device is at least as safe and effective as the legally marketed predicate device.

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.