Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
Revision of previously failed total hip arthroplasty

Device Description

The subject devices, Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeves, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.

This submission proposes a new bioburden reduction manufacturing process that includes a new contact material for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve.

AI/ML Overview

The provided document is a 510(k) summary for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a study with performance metrics in the way one might expect for a diagnostic AI or imaging device.

Therefore, the requested information, particularly regarding acceptance criteria performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment, is not applicable to this type of submission. This submission is for a physical medical device (a hip prosthesis component) and its substantial equivalence is based on technological characteristics and biocompatibility.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity). Instead, they are implied by demonstrating substantial equivalence to a predicate device (K193546 Distal Centralizers). The criteria revolve around showing that the new device shares similar technological characteristics (intended use, indications for use, materials, design features, sterilization) and biocompatibility with the predicate.
Reported Device Performance:
- Non-Clinical Tests: A biocompatibility assessment was performed in accordance with ISO 10993-1. The data confirmed the biocompatibility of the candidate manufacturing process flow for the device in long-term contact with patient bone and tissues. No specific numerical performance metrics are provided, as this is a qualitative assessment of biocompatibility.
- Clinical Tests: None were provided for this submission.

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

Not Applicable. This submission does not involve a "test set" in the context of evaluating an algorithm or AI. The biocompatibility assessment is a laboratory test on device materials, not a study on a human subject population with a test set of data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. Ground truth in the context of expert consensus for diagnostics is not relevant here. Biocompatibility assessment relies on standardized testing procedures and interpretation by qualified laboratory personnel.

4. Adjudication Method for the Test Set

Not Applicable. No test set or expert adjudication is involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not Applicable. This is a physical device, not an AI or diagnostic tool that would involve human readers.

6. If a Standalone Performance (Algorithm Only) Was Done

Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable. For the biocompatibility assessment, "ground truth" would be established by the results of the ISO 10993-1 tests themselves, interpreted against the standard's requirements. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic performance.

8. The Sample Size for the Training Set

Not Applicable. No training set is involved as this is not an AI/algorithm submission.

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

Not Applicable. No training set is involved.

In summary, the provided document is a regulatory submission for a physical medical device, not a diagnostic or AI product. Therefore, most of the requested information about "acceptance criteria" and "studies" related to performance metrics, test/training sets, and expert evaluations is not applicable to this specific type of device and submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

February 7, 2022

Biomet, Inc. Gregory Foster Sr. Specialist Regulatory Specialist 56 East Bell Drive PO Box 587 Warsaw, Indiana 4658

Re: K212431

Trade/Device Name: Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve Regulation Number: 21 CFR 888.3360 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: JDG, LZO Dated: November 11, 2021 Received: November 12, 2021

Dear Gregory Foster:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K212431

Device Name

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

Indications for Use (Describe)

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis

Rheumatoid arthritis

1. Correction of functional deformity

Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
Revision of previously failed total hip arthroplasty

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

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

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510(k) Summary

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact Person:	Gregory FosterSr. Regulatory SpecialistTelephone: (574) 371-0519Fax: (574) 377-3718Gregory.foster@zimmerbiomet.com
Date:	07-Feb-2022
Subject Device:	Trade Name: Biomet Answer/Impact/Integral DistalCentralizer/Centering Sleeve.
	Common Name: Prosthesis, Hip, Femoral Component, Cemented, Metal
Classification Name:	21 CFR 888.3360 Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis.• JDG- Prosthesis, Hip, Femoral Component, Cemented, Metal• LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,Cemented Or Non-Porous, Uncemented
Predicate Device(s):	K193546 Distal CentralizersBiomet, Inc.
Device Description:	The subject devices, Biomet Answer/Impact/Integral DistalCentralizer/Centering Sleeves, are cylindrical components designed toslide onto the distal end of a cemented femoral stem prior to insertion intothe femoral canal.This submission proposes a new bioburden reduction manufacturingprocess that includes a new contact material for the BiometAnswer/Impact/Integral Distal Centralizer/Centering Sleeve.
Indications for Use:	1. Noninflammatory degenerative joint disease including osteoarthritisand avascular necrosis2. Rheumatoid arthritis3. Correction of functional deformity4. Treatment of non-union, femoral neck fracture, and trochantericfractures of the proximal femur with head involvement, unmanageableusing other techniques5. Revision of previously failed total hip arthroplasty
Summary of TechnologicalCharacteristics:	The rationale for substantial equivalence is based on consideration of thefollowing characteristics:• Intended Use: Identical to the predicate• Indications for Use: Identical to the predicate• Materials: Identical to the predicate• Design Features: Identical to the predicate• Sterilization: Identical to the predicate

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Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests: ●

A biocompatibility assessment was performed in accordance O with ISO 10993-1. The data provided by the testing confirmed the biocompatibility of the candidate manufacturing process flow for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve in long-term contact with patient bone and tissues.

Clinical Tests: ●

o None provided

Substantial Equivalence Conclusion

Based on the information contained within this submission, it is concluded that the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve are substantially equivalent to the identified predicate device.

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.