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 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.

AI/ML Overview

The document is a 510(k) Summary for the Oxford® Fixed Lateral Bearing Partial Knee Replacement, seeking substantial equivalence to a previously cleared device (K122277). The modification is a design change to add a chamfer to the anterior corner of the tibial bearing, resulting in asymmetric left and right configurations.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance measures. Instead, the "performance data" section focuses on demonstrating substantial equivalence through non-clinical testing. The conclusion reached is that the subject construct is "substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness."

Acceptance Criteria (Explicitly Stated)	Device Performance (Reported)
Not explicitly stated as numerical performance metrics. The implicit criterion is "substantial equivalence" to the predicate device in terms of safety and effectiveness.	Results indicate that the subject construct is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
(Implied) Biocompatibility	Biocompatible materials of the components are identical to the predicates and have a long history of orthopedic use.
(Implied) Tibial component features	Both the subject and predicate tibial components are D-shaped for lateral use, incorporate the same tibial tray keel, and are offered in the same sizes.
(Implied) Fixation method	Subject and predicate devices are both indicated only for cemented use fixation.
(Implied) Impact of design modification (anterior chamfer) on performance	The design modification (anterior chamfer) reduces the likelihood of femoral impingement and ensures the device will perform within the intended use.

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

The document states "Non-clinical performance testing included cadaver evaluation and MRI justification."

Sample Size for Test Set: Not explicitly stated as a number of samples or subjects. It only mentions "cadaver evaluation," implying a limited set of cadaver knees were used.
Data Provenance: The cadaver evaluation would be considered prospective data collection for the specific purpose of this evaluation. The country of origin for the cadavers is not specified. MRI justification likely refers to engineering analysis or imaging studies to demonstrate the design change.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given it's a cadaver evaluation for a mechanical device modification, formal clinical adjudication methods like 2+1 or 3+1 are unlikely to have been employed in the same way they would for diagnostic imaging studies. The evaluation would likely have been conducted by biomechanical engineers or orthopedic surgeons.

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

MRMC Study Done? No. The product is a knee implant, not a diagnostic imaging AI algorithm that would typically undergo MRMC studies.

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

Standalone Study Done? Not applicable. This is a physical medical device (knee implant), not an AI algorithm. The performance evaluation focuses on the mechanical and functional aspects of the implant itself, primarily through non-clinical testing.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device modification is established through physical and mechanical evaluation (cadaver evaluation), engineering justification, and comparison to the safety and effectiveness profile of the legally marketed predicate device. The goal is to show the modified device functions as intended without introducing new safety or effectiveness concerns, akin to demonstrating physical equivalence.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm that requires a training set in the conventional sense. The "training" for the design comes from extensive biomechanical and materials science knowledge, as well as experience with the predicate device.

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

How Ground Truth for Training Was Established: Not applicable. See point 8. The design process for a physical device relies on established engineering principles, material properties, biomechanical considerations, and clinical experience with similar devices, rather than a "ground truth" derived from a specific "training set" of data.

In summary: This document pertains to a 510(k) submission for a physical medical device (a knee implant modification), not a software or AI-driven diagnostic device. Therefore, many of the typical acceptance criteria and study components relevant to AI/software performance (like human reader studies, training/test sets, expert adjudication for image interpretation) are not applicable or described in this type of submission. The focus is on demonstrating "substantial equivalence" through non-clinical (cadaver and engineering) testing to a predicate device.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized, blocky font, with a registered trademark symbol in the upper right corner. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.

510(k) SUMMARY

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

Applicant / Sponsor
Name	Biomet UK, Ltd.
Address	Waterton Industrial EstateBridgend, United Kingdom CF31 3XA
EstablishmentRegistration Number	3002806535
Name of contactperson	Jason HeckamanRegulatory Affairs Project Manager
Phone number	(574) 371-3707
Fax number	(574) 372-1683
Date prepared	December 20, 2013
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 (21 CFR §888.3530)
Classification panel	Orthopedic
Regulation	21 CFR §888.3530
Product Code(s)	HRY
Legally marketeddevice(s) to whichequivalence is claimed	K122277 Oxford Fixed Lateral Bearing Partial KneeReplacement
Reason for 510(k)submission	Modification to tibial bearing design
Device description	The Oxford Fixed Lateral Bearing Partial Knee Replacementis a partial knee replacement option that consists of afemoral component (single and twin peg versions)manufactured from CoCrMo (ASTM F-75), a tibial tray/platemanufactured from CoCrMo (ASTM F-75), and a fixed tibialbearing of direct compression molded (DCM) polyethylene(UHMWPE) conforming to ASTM F-648 which is moldedonto the tibial tray.
Intended use of the device	The subject of this submission is a design modification to add a chamfer to the anterior corner of the tibial bearing, resulting in asymmetric left and right configurations rather than the symmetrical design cleared in K122277.Unicondylar Knee implant intended to replace part of a knee joint when used in conjunction with a femoral and tibial component.
Indications for use	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.
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. Both the subject and predicate tibial components are D-shaped for lateral use, incorporate the same tibial tray keel, and are offered in the same sizes. The subject tibial bearing differs slightly from the K122277 bearing in that the subject design has been modified to include an anterior chamfer to reduce the likelihood of femoral impingement. The subject and predicate devices are both indicated only for cemented use fixation.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE

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MANUFA CORP.

Non-clinical performance testing included cadaver evaluation and MRI justification.

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Image /page/2/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the words "MANUFACTURING CORP." underneath. The text is in black and the background is white. The logo is simple and professional.

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 subject Oxford Fixed Lateral Bearing Partial Knee Replacement devices have been shown to be substantially equivalent to the predicate devices (K122277). Results of preclinical tests/engineering justification/cadaver evaluation and the similarities with legal marketed predicated devices indicate the device will perform within the intended use and no new issues of safety or effectiveness have been raised.

Santa DI 2808 Liver Unen Far 574 267 8137

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The text is horizontally aligned and appears to be part of a title or heading. The background is plain and white, providing a clear contrast to the text.

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

March 28, 2014

Biomet, Incorporated Jason Heckaman Regulatory Affairs Project Manager 56 East Bell Drive Warsaw, Indiana 46581

Re: K133940

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: Class II Product Code: HRY Dated: March 7, 2014 Received: March 10, 2014

Dear Mr. Heckaman:

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. Ilsting 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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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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

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

K133940 510(k) Number (if known): _

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.

AND/OR

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use _ NO (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

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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.