The Versa-Fx Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with verticular extension, and in the patient with multiple lower extremity fractures.

Supracondylar: The Versa-Fx II Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intra-articular extension, and in the patient with multiple lower extremity fractures.

Proximal Femur: The Versa-Fx II Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).

The Free-Lock Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, osteotomies, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).

Device Description

The subject devices are similar in that they are used for either supracondylar or proximal femur fracture fixation. The systems contain supracondylar tube/plates with angles of 90° and 95° and/or proximal femur tube/plates with angles from 130° to 150°. These systems share the lag and compression screws.

AI/ML Overview

This document is a 510(k) summary for the Zimmer Femoral Fixation Systems, which are medical devices used for internal fixation of certain femoral fractures. It describes changes made to existing devices and asserts their substantial equivalence to predicate devices. As such, it does not detail acceptance criteria or a study proving that an AI/Machine Learning device meets specific performance criteria.

Therefore, most of the requested information regarding AI device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, and adjudication methods is not applicable to this document. This document focuses on the mechanical and material aspects of surgical implants.

However, I can extract information related to the device and its assessment where applicable:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, or accuracy) because it is not an AI/ML device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through:

Acceptance Criterion	Reported Device Performance / Assessment
Non-Clinical Performance:
Shelf Life	Accelerated aging testing showed a shelf life of 10 years.
Biocompatibility	Testing conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58) passed all tests.
Performance Evaluation	A combination of performance testing (single cycle compression bending strength, fatigue compression bending strength and moment, four-point bend testing) and engineering analyses (beam bending cross-sectional analysis) demonstrated safety, effectiveness, and substantial equivalence to predicate devices.
Clinical Performance:
Substantial Equivalence	Clinical trial data and conclusions were not needed to show substantial equivalence.

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

Not applicable. This is not an AI/ML device that uses test sets of data for performance evaluation. The "test set" here refers to the actual physical devices undergoing mechanical and biocompatibility testing. The data provenance is internal to Zimmer, Inc. and its testing facilities, following international (ISO) and US (FDA) standards.

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)

Not applicable, as this is not an AI/ML device requiring expert-established ground truth. Expert involvement would be in the design and interpretation of the engineering and biocompatibility tests, but not in establishing a "ground truth" for a dataset.

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

Not applicable. There is no adjudication method for a test set in the context of an AI/ML device. The "test set" in this context refers to physical devices undergoing standardized mechanical and biological tests, whose results are interpreted by qualified engineers and scientists.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable in the context of AI/ML. For this medical device, the "ground truth" for its performance is established through:

Physical and biological testing: Adherence to established engineering standards (e.g., strength, fatigue) and biological safety standards (biocompatibility).
Comparison to predicate devices: The "ground truth" of safety and effectiveness is largely based on the historical performance and regulatory clearance of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other, with a flowing element beneath them.

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

Zimmer, Incorporated Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K150818 Trade/Device Name: Versa-Fx Femoral Fixation System. Versa-Fx II Femoral Fixation System, Free-lock Femoral Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT. HRS Dated: March 26, 2015 Received: March 27, 2015

Dear Mr. McKelvey:

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

May 1, 2015

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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.

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

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

Sincerely yours.

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150818

Device Name

Versa-Fx Femoral Fixation System

Indications for Use (Describe)

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

2 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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K150818

Device Name

Versa-Fx II Femoral Fixation System

Indications for Use (Describe)

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

2 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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K150818

Device Name

Free-Lock Femoral Fixation System

Indications for Use (Describe)

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

2 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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/5/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a blue letter Z inside of a blue circle. Below the circle is the word "zimmer" in lowercase blue letters.

510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Stephen H. McKelvey, MA, RACSenior Project Manager, Regulatory AffairsTelephone: 574-372-4944Fax: (574) 372-4605
Date:	March 26, 2015
Trade Name:	This is a bundled traditional 510(k). The trade names ofthe three devices bundled in this submission are:
	1) Versa-Fx® Femoral Fixation System2) Versa-Fx® II Femoral Fixation System2) Free-Lock® Femoral Fixation System
Common Name:	Appliance, Fixation, Nail/Blade/Plate Combination,Multiple Component
Classification Namesand References:	Single/multiple component metallic bone fixationappliances and accessories (21 CFR § 888.3030, KTT)
Classification Panel:	Orthopedics/87
Predicate Device(s):	Dynamic Condylar Screw (DCS), manufactured bySynthes (K840954, cleared May 11, 1984).
	Versa-Fx Femoral Fixation System, manufactured byZimmer (K954555, cleared January 26, 1996).
	Dynamic Hip Screw (DHS), manufactured by Synthes(K791619, cleared August 28, 1979)

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Device Description:

Intended Use:

Zimmer is requesting clearance for modifications to the Versa-Fx, Versa-Fx II and Free-Lock Femoral Fixation Systems. The subject devices are similar in that they are used for either supracondylar or proximal femur fracture fixation. The systems contain supracondylar tube/plates with angles of 90° and 95° and/or proximal femur tube/plates with angles from 130° to 150°. These systems share the lag and compression screws.

Versa-Fx Femoral Fixation System:

The Versa-Fx Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intraarticular extension, and in the patient with multiple lower extremity fractures.

Versa-Fx II Femoral Fixation System:

Proximal Femur: The Versa-Fx II Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, osteotomies, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).

Free-Lock Femoral Fixation System:

Comparison to Predicate Device: The subject devices incorporate similar or identical materials, similar or identical indications for use, similar or identical sizes of implants, and the same technological characteristics as the predicate devices.

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Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

o Shelf Life - Accelerated aging testing conducted shows that the sterile devices included in this submission have a shelf life of 10 years.
. Biocompatibility - Biocompatibility testing of the subject devices was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
. Performance Evaluation – A combination of performance testing (single cycle compression bending strength, fatigue compression bending strength and moment, four-point bend testing) and engineering analyses (beam bending cross sectional analysis) as appropriate demonstrate the subject devices are safe and effective and substantially equivalent to the predicate devices.

Conclusions: The data presented in this submission demonstrates that the subject devices are substantially equivalent to their respective predicate devices.

Clinical Performance and Conclusions:

Clinical trial data and conclusions were not needed for these devices to show substantial equivalence.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.