Biomet's MAK OSS Femoral Knee Components are intended for use in conjunction with the OSS System for total knee replacement procedures. Specific indications for the OSS System are:

Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
Correction of varus, valgus or post-traumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Ligament deficiencies.
Tumor resections.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. *
Revision of previously failed total joint arthroplasty.
Trauma.
These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).

Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:

Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Tumor resections.
Revision of previously failed total joint arthroplasty.
Trauma.

Device Description

The MAK OSS Femoral Knee Components are intended to be used as an optional femoral knee component for use in coniunction with the cleared Orthopedic Salvage System. The MAK OSS Femoral Knee Components include either resurfacing or segmental femoral components that utilize the yoke and axle of the OSS System but limit extension of the knee to limit or prevent hyperextension.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "MAK OSS Femoral Knee Components." It focuses on design modifications to a locking pin within the existing device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Locking pin easy insertion	Testing demonstrated that the locking pins could be easily inserted.
Adequate extraction force	Testing demonstrated that the locking pins still maintained adequate extraction force.
Design modification does not adversely affect insertion.	Verified through non-clinical testing.
Design modification does not adversely affect extraction.	Verified through non-clinical testing.
Intended Use and Indications for Use remain identical to predicate systems.	Stated in the "Technological Characteristics" section and confirmed by FDA's substantial equivalence determination.
Made from same wrought Co-Cr-Mo alloy conforming to ASTM F-1537.	Stated in the "Technological Characteristics" section.

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

The document does not specify a numerical sample size for the test set used in the non-clinical testing. It only states that "Verification testing was conducted."

The data provenance is not explicitly mentioned (e.g., country of origin). Since this is a 510(k) submission to the FDA, it can be inferred that the testing and data generation occurred within a context relevant to US regulatory standards, likely in the US or by a US-based or affiliated entity. The testing was non-clinical, involving mechanical tests, not human subjects.

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

This document describes non-clinical, mechanical testing. Therefore, there were no human experts establishing a "ground truth" in the clinical sense (e.g., diagnosis, outcome assessment). The "ground truth" for this engineering verification would be the objective measurements of insertion and extraction forces against predefined engineering specifications or benchmarks for the predicate device. The experts involved would be biomechanical engineers or test technicians, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. This was non-clinical testing against engineering specifications, not a study involving human interpretation or subjective assessments that would require adjudication.

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 a 510(k) submission for a mechanical medical device (femoral knee components) and does not involve AI, human readers, or image interpretation.

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

Not applicable. This device is a mechanical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical testing was based on objective engineering measurements of insertion and extraction forces, compared against predefined specifications or performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device. The term "training set" is generally used in the context of supervised learning, where an algorithm learns from labeled data.

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

Not applicable, as there is no "training set" for this mechanical device.

Summary

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510(k) Summary

Preparation Date:

Applicant/Sponsor:

17 October, 2013

Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46582 FDA Registration #: 1825034

Contact Person:

Gary Baker Sr. Regulatory Specialist 56 East Bell Drive Warsaw, IN 46582 574-267-6639 Ext. 1568 574-371-1027 garv.baker(@biome1.com

Proprietary Name:

Common Name:

. Rotating Hinged Knee

MAK OSS Femoral Knee Components

Classification Code(s)/Name(s): KRO

888.3510 (KRO) - Knee joint femorotibial metal/polymer constrained cemented prosthesis

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

K083779 - MAK OSS Femoral Knee Components (Biomet)

K123501 - Orthopedic Salvage System (Biomet)

Device Description:

Intended Use:

The MAK OSS Femoral Knee Components are intended for cemented use only.

Mailing Address:
P.O Box 587
Warsaw, IN 46581-0587
Toll Free. 800.348 9500
Office: 574 267.6639
Main Fax: 574 267.8137
www.biomet.com

Shipping Address:
56 East Bell Drive
Warsaw, IN 46582

OCT 24 2013

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Indications For Use:

Biomet's MAK OSS Femoral Knee Components are intended for use in conjunction with the OSS System for total knee replacement procedures. Specific indications for the OSS System are:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
1. Correction of varus, valgus or post-traumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
1. Ligament deficiencies.
1. Tumor resections.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. *
1. Revision of previously failed total joint arthroplasty.
1. Trauma.

These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).

*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.

When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:

I. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
1. Tumor resections.
1. Revision of previously failed total joint arthroplasty.
1. Trauma.

Proposed Change(s):

This Traditional 510(k) is being submitted for design modifications made to the cleared Biomet MAK OSS Femoral Knee Components locking pin.

Technological Characteristics:

The modified MAK OSS locking pin is manufactured from the same wrought Co-Cr-Mo alloy conforming to ASTM F-1537 as the predicate MAK OSS locking pin. The pin diameter has been reduced by 0.002 inches and is longer than the predicate pin. It incorporates tabs to lock the pin in place. No other changes to the MAK OSS components are proposed by this submission. The intended use and the indications for use are identical to the predicate Systems.

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Non-Clinical Testing:

Verification testing was conducted to demonstrate that the design modification made to the locking pin would not adversely affect the insertion or extraction of the locking pin. The testing demonstrated that the locking pins could be easily inserted and still maintained adequate extraction force.

Clinical Testing:

Clinical testing was not required to demonstrate substantial equivalence of the design modifications proposed to the cleared predicate devices.

All trademarks are property of Biomet, Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is black and white.

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

October 24, 2013

Biomet Orthopedics Corporation Mr. Gary Baker Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46582

Re: K131393

Trade/Device Name: MAK OSS Femoral Knee Components Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: July 30, 2013 Received: August 2, 2013

Dear Mr. Baker:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Gary Baker

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/definil.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 Small Manufacturers, International and Consumer Assistance 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,

Ering Keith

for

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): __K131393

Device Name: MAK OSS Femoral Knee Components

Indications For Use:

Biomet's MAK OSS Femoral Knee Components are intended for use in conjunction with the OSS System for total knee replacement procedures. Specific indications for the OSS System are:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
1. Correction of varus, valgus or post-traumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
1. Ligament deficiencies.
1. Tumor resections.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. *
1. Revision of previously failed total joint arthroplasty.
1. Trauma.

These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).

Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.

When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:

Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.

1. Tumor resections.
1. Revision of previously failed total joint arthroplasty.
1. Trauma.

Over-The-Counter Use_ NO_ ____(Part 21 CFR Prescription Use YES 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

Page 1 of 1

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.