LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE

• K Number: K012551
• Device Name: LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
• Manufacturer: BIOMET, INC.
• Date Cleared: 2002-01-30 ( 176 days)
• Product Code: KWI
• Regulation Number: 888.3170
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K002644 , K991915
• Predicate For: K040611

Intended Use

The Liverpool Radial Head Replacement Device is intended for:

• 1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, creptation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
  • a) Joint destruction and/or subluxation visible on x-ray
  • b) Resistance to conservative treatment
• 2. Primary replacement after fracture of the radial head
• 3. Symptomatic sequelae after radial head resection
• 4. Revision following failed radial head arthroplasty

The device is intended for single use with bone cement.

Device Description

The Biomet Liverpool Radial Head Replacement Device is a one-piece cobalt alloy device. The tapered stem is centered into the intramedullary canal of the radius. The articulating surface is a highly polished concave surface to articulate with the capitellum of the humerus. Except for the articulating surface, the device is roughened by a process called "Microbond" Coating. The device is available in two sizes, 16mm and 18mm. The 16mm device has a stem length of 32.76mm and head heights that vary from 14 to 24mm. The 18mm device has a stem length of 32.76mm and head heights that vary from 14 to 24mm.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Liverpool Radial Head Replacement Device. Such notifications are for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a study. Therefore, most of the information requested in your prompt is explicitly not applicable or not provided in this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable/Not Provided. This 510(k) is a submission for substantial equivalence based on technological characteristics and intended use, not performance against specific acceptance criteria from a study.

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

Not Applicable/Not Provided. The document explicitly states: "Non-Clinical Testing and Clinical Testing: none provided as a basis of substantial equivalence." This means no test set was used to evaluate the device against specific performance criteria in a study for this submission.

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

Not Applicable/Not Provided. No test set means no ground truth was established by experts for performance evaluation in this submission.

4. Adjudication Method for the Test Set

Not Applicable/Not Provided. No test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not Applicable/Not Provided. No clinical testing was provided, so no MRMC study was conducted or reported.

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

Not Applicable/Not Provided. This is a physical orthopedic implant device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is irrelevant. No standalone testing of the device's performance against specific criteria was reported or required for this type of submission.

7. The Type of Ground Truth Used

Not Applicable/Not Provided. As no new performance study was conducted for this 510(k) submission, the concept of a "ground truth" for the device's performance is not present in this document. The submission relies on the substantial equivalence to predicate devices that are already legally marketed.

8. The Sample Size for the Training Set

Not Applicable/Not Provided. This is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" is not applicable.

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

Not Applicable/Not Provided. As above, the concept of a "training set" and its ground truth is not applicable to this type of device and submission.

In summary, this 510(k) submission demonstrates substantial equivalence by comparing the technological characteristics (materials, design, sizing, and indications) of the Liverpool Radial Head Replacement Device to legally marketed predicate devices, rather than through new performance studies with specific acceptance criteria.

Summary

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JAN 3 0 2002

012551
page 1 of 1

HEADQUARTERS CORPORATE

Summary of Safety and Effectiveness

Applicant/Sponsor:

Biomet Orthopedics, Inc. 56 Bell East Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Patricia Sandborn Beres Contact Person: Telephone: [phone]

Proprietary Name: Liverpool Radial Head Replacement Device

Common Name: Elbow hemi-prosthesis

Classification Name: Elbow joint radial (hemi-elbow) polymer prosthesis (21 CFR 888.3170)

Legally Marketed Devices to Which Substantial Equivalence Is Claimed: Radial Head Surface Legaly Marketed Devices to Which Gubalantar Equivalent (Avanta Orthop., Inc., K002644) and Modular Radial Head (Wright Medical Tech. Inc., K991915)

Device Description: The Biomat Liverpool Radial Head Replacement Device Is a one-prese cobalt alloy Device Description. The Gioner Elverpoor road. The tapered stem is centeried into the surface to article intramedialy canal of the regions, the stem and the a highly pollished concave surface to anticulated by a Intramedulary canal of the radios. The enticulating surface, the device is roughened by a with the flatural bother of the runers. Except for the artealers, 16mm and 18mm. The 16mm device one of the Mebroond "" Coaling." The Good is available in the form. The 18mm device has a stem longth of 32.76mm and head heights that vary from 14 to 24mm.

Intended Use: The Liverpool Radial Head Replacement Device is intended for:

• Ba Use. The Elverpool Natian Noplasonians or post-traumatic disabilities presenting pain, creplation, 1) replacement of the radio-humeral and/or proximal radio-ulnar joint with:
  • Joint destruction and/or subluxation visible on x-ray a)
  • Resistance to conservative treatment b)
  • Primary replacement after fracture of the radial head
• 2. Symptomatic sequelae after radial head resection 3)
• Revision following failed radial head arthroplasty 4)

The device is intended for single use with bone cement.

Summary of Technologies: The technological characteristics (materials, design, sizng, and indications) of the Liverpool Radial Head Replacement Device are similar to or Identical to the predicate devices.

Non-Clinical Testing and Clinical Testing: none provided as a basis of substantial equivalence

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

1

OFFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2002

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet P. O. Box 587 Warsaw, Indiana 46581-0587

Re: K012551

Trade Name: Liverpool Radial Head Replacement Device Regulation Number: 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: December 3, 2001 Received: December 4, 2001

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Beres

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualled of a basetainter ice complies with other requirements mean that I DA has made a decommistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I edelar statutes and rogarments, including, but not limited to: registration You must comply with an the Fee s requirements (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 607), labality systems (QS) regulation (21 CFR Part 820); and if requirents as set fortif in the quality is a control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to objall made .
Premarket notification. The FDA finding of substantial equivalence of your device to a premiarket notification. The PDF mising or classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and II you desire specific advice for your acvices diagnostic devices), please contact the Office of additionally 21 OFF 2 01 1 94-4659. Additionally, for questions on the promotion and Compliance at (301) 591 -1659. Free of Compliance at [phone]. advertising of your arregulation entitled, "Misbranding by reference to premarket Also, please note the regulation only of ther general information on your responsibilities under notheation (210) It Full 0011) - Division of Small Manufacturers, International and the Act may be obtained from the DP Hoston of [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark McMullen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K012551

Device Name: Liverpool Radial Head Replacement Device

Indications For Use:

The Liverpool Radial Head Replacement Device is intended for:

• 1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, creptation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
  • a) Joint destruction and/or subluxation visible on x-ray
  • b) Resistance to conservative treatment
• 2. Primary replacement after fracture of the radial head
• 3. Symptomatic sequelae after radial head resection
• 4. Revision following failed radial head arthroplasty

The device is intended for single use with bone cement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ) (Per 21 CFR 801.109)

Mark OR A Milkersen

Division Sign-Off Division of General, Restorative and Neurological Dev

510('') "mber

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.

(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.