Biomet Tibial Trays are modular components that are part of a total knee implant system intended to replace the damaged or diseased knee joint during total knee arthroplasty.

Indications for use are as follows:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.

The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) devices and allpolyethylene patellar components are indicated for cemented application only.

Regenerex components are intended only for uncemented biologic fixation application.

Device Description

The subject Biomet Tibial Trays are available in four design configurations – Interlok, porous, stemmed, and offset. The trays, as a system construct, are compatible with existing, legally marketed Biomet femoral components, tibial bearings, patella components, stems, and various auxiliary components, including augment blocks and wedges.

This submission includes a modification to remove the shot peen operation from the manufacturing process of the subject Biomet Tibial Trays. In addition, a new cementing technique option is being introduced for the Interlok tibial trays. The technique is executed via use of new implant-specific instrumentation referred to as CementON Tibial Molds.

AI/ML Overview

This document is a 510(k) premarket notification for Biomet Tibial Trays. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a device performance study with specific acceptance criteria in the context of clinical AI/software performance.

Therefore, many of the requested categories related to clinical study design, AI performance, ground truth, and expert evaluation cannot be answered from the provided text.

However, I can extract information regarding the non-clinical performance tests that were conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Tibial Tray Cyclic Fatigue Testing	Not explicitly stated, but implied to be sufficient for demonstrating substantial equivalence and safety.	Data collected supported substantial equivalence (details not provided in this summary).
I-beam Implant Pullout Force from a Cement Mantle after CementON or Manual Cement Application	Not explicitly stated, but implied to be sufficient for demonstrating substantial equivalence and safety.	Data collected supported substantial equivalence (details not provided in this summary).
Finned Implant Pullout Force from a Cement Mantle after CementON or Manual Cement Application	Not explicitly stated, but implied to be sufficient for demonstrating substantial equivalence and safety.	Data collected supported substantial equivalence (details not provided in this summary).

2. Sample size used for the test set and the data provenance
This information is not provided in the document for the non-clinical tests. The document states "Clinical data was not required to establish substantial equivalence".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical ground truth was established from experts for this submission. The tests were non-clinical mechanical or material tests.

4. Adjudication method for the test set
Not applicable. No human adjudication method was described as these were non-clinical tests.

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
No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (tibial trays) which is a physical implant, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a physical medical device, not an algorithm.

7. The type of ground truth used
For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards relevant to tibial trays, but these specific criteria are not detailed in this summary.

8. The sample size for the training set
Not applicable. This submission is for a physical medical device, not an AI/ML algorithm that would typically have a training set.

9. How the ground truth for the training set was established
Not applicable.

Summary

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

December 23, 2014

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

Re: K142933 Trade/Device Name: Biomet Tibial Trays Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: JWH, MBH, MBV Dated: October 27, 2014 Received: October 28, 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, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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,

Lori A. Wiggins -S

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 STATEMENT

510(k) Number (if known): K142933

Device Name: Biomet Tibial Trays

INDICATIONS FOR USE:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.

The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.

Regenerex components are intended only for uncemented biologic fixation application.

Prescription Use |X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Orthopedic Devices 510(k) Number: K142933

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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 Biomet Tibial Trays 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:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact:	Jason HeckamanProject Manager, Regulatory AffairsPhone: 574-371-3707Fax: 574-372-1683
Date:	October 30, 2014
Subject Device:	Trade Name: Biomet Tibial TraysCommon Name: Knee ProsthesisClassification Name:• JWH - prosthesis, knee, patellofemorotibial, semi-constrained,cemented, polymer/metal/polymer (21 CFR §888.3560)• MBH - prosthesis, knee, patello/femorotibial, semi-constrained,uncemented, porous, coated, polymer/metal/polymer (21 CFR §888.3565)• MBV-prosthesis, knee, patellofemorotibial, semi-constrained,UHMWPE, pegged, cemented, polymer/metal/polymer (21 CFR §888.3560)

Legally marketed devices to which substantial equivalence is claimed:

K915132 MCK (Maximum Congruent Knee) System
K010212 Offset Tibial Tray
K033489 Biomet's Non-Cemented Porous Coated Knee Components

Device Description

This submission includes a modification to remove the shot peen operation from the manufacturing process of the subject Biomet Tibial Trays. In addition, a new cementing

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technique option is being introduced for the Interlok tibial trays. The technique is executed via use of new implant-specific instrumentation referred to as CementON Tibial Molds.

Intended Use and Indications for Use

Biomet Tibial Trays are modular components that are part of a total knee implant system intended to replace the damaged or diseased knee joint during total knee arthroplasty.

Indications for use are as follows:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.

The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.

Regenerex components are intended only for uncemented biologic fixation application.

Summary of Technological Characteristics

The subject changes include removal of the shot peen operation from the manufacturing process and the addition of a new cementing technique option for the Interlok trays via use of new implant-specific instrumentation.

The subject modifications do not result in any changes to the intended use, indications for use, materials, design features, or sterilization of the Biomet Tibial Trays.

Summary of Performance Data (Nonclinical and/or Clinical)

. Non-Clinical Tests
- o Tibial Tray Cyclic Fatigue Testing
- I-beam Implant Pullout Force from a Cement Mantle after CementON or Manual o Cement Application
- Finned Implant Pullout Force from a Cement Mantle after CementON or Manual o Cement Application
. Clinical Tests
- Clinical data was not required to establish substantial equivalence between the o subject Biomet Tibial Trays and the predicate device.

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Substantial Equivalence Conclusion

Based on the similarities in design, function, intended use and fundamental scientific technology, the devices that are the subject of this submission are similar to the predicate devices and do not introduce any new risks of safety or efficacy. Therefore, Biomet concludes that the subject devices are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.