Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment.

The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement.

The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement.

Device Description

The Oxford Fixed Lateral Bearing Partial Knee Replacement is a partial knee replacement option that consists of a legally marketed femoral component (single and twin peg versions) manufactured from CoCrMo (ASTM F-75), a tibial tray/plate manufactured from CoCrMo (ASTM F-75), and a fixed tibial bearing of direct compression molded (DCM) polyethylene (UHMWPE) conforming to ASTM F-648 which is molded onto the tibial tray. The femoral and tibial tray components have a coarse grit blast surface finish the same as that of the predicates. The tibial component (metal tray plus polyethylene) will be available in 6 sizes (A, B, C, D, E and F) and 5 overall thicknesses (8.0, 9.0, 10.0, 11.0, 12.0mm). The subject tibial component is D-shaped. The subject device is indicated for lateral use only for cemented use fixation.

AI/ML Overview

The Oxford Fixed Lateral Bearing Partial Knee Replacement is a partial knee replacement that was evaluated in a non-clinical study to demonstrate its substantial equivalence to predicate devices (K042093 and K011138).

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria	Reported Device Performance
Technological Characteristics	Substantially equivalent to predicate devices (K042093, K011138) in materials, principle of operation, and similar design elements.	Device maintains same materials (Co-Cr-Mo, UHMWPE) and principle of operation. Femoral component designs (single/twin pegged) and dimensions are the same as predicate K011138. Tibial component is D-shaped for lateral use (vs. tear-shaped for predicate K042093, which allows for medial/lateral). Both incorporate a keel. Indicated for cemented use.
Contact Area	Not explicitly stated, but implied to be acceptable for safe and effective function compared to predicates.	Preclinical performance tests provided to address contact area. Results indicate substantial equivalence.
Range of Motion	Not explicitly stated, but implied to be acceptable for safe and effective function compared to predicates.	Preclinical performance tests provided to address range of motion. Results indicate substantial equivalence.
Tibial Strength	Not explicitly stated, but implied to be acceptable for safe and effective function compared to predicates.	Preclinical performance tests provided to address tibial strength. Results indicate substantial equivalence.
Magnetic Resonance Compatibility	Not explicitly stated, but implied to be acceptable.	A Magnetic Resonance rationale was provided.
Clinical Performance	No specific clinical performance acceptance criteria were provided as the basis for substantial equivalence for the new device construct.	No clinical data was provided.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of human subjects or a dataset. The evaluation was based on preclinical performance tests/engineering rationales. The document does not provide details on the sample sizes for these preclinical tests or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The evaluation was based on non-clinical engineering tests and comparison to existing predicate devices, not on a ground truth established by medical experts for a diagnostic or classification task.

4. Adjudication method for the test set

This information is not applicable as the evaluation was based on non-clinical engineering tests, not expert review of a test set.

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

An MRMC comparative effectiveness study was not done. This device is a knee implant, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a physical knee implant, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by engineering rationales and physical performance testing according to established methods (e.g., ASTM standards for materials). The primary method for demonstrating equivalence was direct comparison of the new device's characteristics and performance in these tests to those of the legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable. The device is a physical knee implant, not an algorithm that requires a training set.

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

This information is not applicable.

Summary

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K1222277

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OCT 2 2 2012

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510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

Submitter Information
Name	Biomet Manufacturing Corp.
Address	56 East Bell DriveWarsaw, IN 46581-0857
Phone number	(574) 267-6639
Fax number	(574) 372-1718
EstablishmentRegistration Number	1825034
Name of contactperson	Elizabeth Wray
Date prepared	July 25, 2012
Name of device
Trade or proprietaryname	Oxford Fixed Lateral Bearing Partial Knee Replacement
Common or usualname	Unicondylar Knee Prosthesis
Classification name	Knee joint femorotibial metal/polymer semi-constrainedcemented prosthesis (21CFR §888.3530)
Classification panel	Orthopedic
Regulation	21CFR §888.3530
Product Code(s)	HRY
Legally marketeddevice(s) to whichequivalence is claimed	K042093 Vanguard M Series Unicondylar Tibial BearingsK011138 Oxford Unicompartmental Knee Femoral Component
Reason for 510(k)submission	New Device Construct
Device description	The Oxford Fixed Lateral Bearing Partial Knee Replacementis a partial knee replacement option that consists of alegally marketed femoral component (single and twin pegversions) manufactured from CoCrMo (ASTM F-75), a tibialtray/plate manufactured from CoCrMo (ASTM F-75), and afixed tibial bearing of direct compression molded (DCM)polyethylene (UHMWPE) conforming to ASTM F-648 whichis molded onto the tibial tray. The femoral and tibial tray
	components have a coarse grit blast surface finish the sameas that of the predicates. The tibial component (metal trayplus polyethylene) will be available in 6 sizes (A, B, C, D, Eand F) and 5 overall thicknesses (8.0, 9.0, 10.0, 11.0,12.0mm). The subject tibial component is D-shaped. Thesubject device is indicated for lateral use only for cementeduse fixation.
Intended use of thedevice	Unicondylar Knee implant intended to replace part of a kneejoint when used in conjunction with a femoral and tibialcomponent.
Indications for use	Partial replacement of the articulating surfaces of the kneewhen only one side of the knee joint is affected due to thecompartmental primary degenerative or post-traumaticdegenerative disease, previous tibial condyle or plateaufractures, deformity or revision of previous partialarthroplasty in the affected compartment.
	The Oxford Fixed Lateral bearings are indicated for use inthe lateral compartment and intended to be implanted withbone cement.
	The Oxford Femoral components are indicated for use inthe lateral compartment for a fixed bearing application.They are intended to be implanted with bone cement.

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Summary of the technological characteristics of the device compared to the predicate

The Oxford Fixed Lateral Bearing Partial Knee Replacement is a partial knee replacement option that consists of a legally marketed femoral component (single and twin peg versions) manufactured from CoCrMo (ASTM F-75), a tibial tray/plate manufactured from CoCrMo (ASTM F-75), and a fixed tibial bearing of direct compression molded (DCM) polyethylene (UHMWPE) conforming to ASTM F-648 which is molded onto the tibial tray. The biocompatible materials of the components are identical to the predicates and have a long history of orthopedic use. The tibial component is D-shaped for lateral use while the K042093 tibial component is tear shaped for lateral and medial use. Both the subject tibial component and the K042093 predicate incorporate a keel. The subject device is indicated only for cemented use fixation as in predicates. A tabular summary of the

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technological characteristics is provided below.
Characteristic	Subject Device	Predicate
Design - Femoral	Single and Twin Pegged Femorals	K011138
Design - Tibial	D-Shaped	K042093
Material	Co-Cr-MoUHMWPE	K042093 K011138
Principal of operation	Replace articulating surfaces of knee	K042093 K011138
Dimensions - Femoral	X-small, Small, Med, Large, X-Large	K011138
Dimensions - Tibial	A, B, C, D, E, F	K042093
Component	PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Performance Test Summary-New Device

The Oxford Fixed Lateral Partial Knee Replacement components have the same basic technological characteristics as the predicate devices except for slight modifications to the general design as described in this 510(k) notification. Preclinical performance tests/rationales were provided to address the subject construct's Contact Area, Range of Motion, and Tibial Strength. A Magnetic Resonance rationale was also provided. Results indicate that the subject construct is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Clinical Performance Data/Information: None provided as a basis for substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The results of preclinical tests/engineering rationales and the similarities with legally marketed devices indicate the devices will perform within the intended use, and do not raise any new safety and efficacy issues.

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

Biomet Manufacturing Corp. % Ms. Elizabeth Wray Senior Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K122277

Trade/Device Name: Oxford Fixed Lateral Bearing Partial Knee Replacement. Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: July 26, 2012 Received: July 30, 2012

Dear Ms. Wray:

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

OCT 2 2 2012

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Page 2 – Ms. Elizabeth Wray

device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K | 22277

Device Name: Oxford Fixed Lateral Bearing Partial Knee Replacement

Indications For Use:

The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement.

The Oxford Femoral components are indicated for use in the lateral compartment for a fixed . bearing application. They are intended to be implanted with bone cement.

Prescription Use ___ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashb

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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V122277 510(k) Number _

Regulation Number and Section

§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.