MODULAR RADIAL HEAD REPLACEMENT DEVICE

K040611 · Biomet, Inc. · KWI · Jun 4, 2004 · Orthopedic

Device Facts

• Record ID: K040611
• Device Name: MODULAR RADIAL HEAD REPLACEMENT DEVICE
• Applicant: Biomet, Inc.
• Product Code: KWI · Orthopedic
• Decision Date: Jun 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modular 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 Story

Modular radial head hemi-prosthesis; two-piece design with Ti-6Al-4V stem and Co-Cr-Mo head. Components connect via dove-tail joint secured by locking screw. Stem cemented into intramedullary canal of radius; head articulates with humerus and ulna. Available in multiple diameters and heights. Used by orthopedic surgeons in clinical/surgical settings to restore joint function and alleviate pain in patients with radial head pathology. Device provides mechanical replacement of damaged radial head; output is physical restoration of joint anatomy. Benefits include pain reduction and improved range of motion.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

Two-piece hemi-prosthesis; stem material: Ti-6Al-4V; head material: Co-Cr-Mo. Stem features roughened Bond Coat surface. Connection: dove-tail joint with locking screw. Fixation: bone cement. Dimensions: 18mm, 20mm, 22mm head diameters; head heights 8-20mm. Sterilization: not specified.

Indications for Use

Indicated for patients requiring radial head replacement due to degenerative or post-traumatic disabilities (pain, crepitation, decreased motion, joint destruction, subluxation), radial head fractures, sequelae post-resection, or revision of failed arthroplasty. Contraindicated for patients not requiring bone cement or those where conservative treatment is sufficient.

Regulatory Classification

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.

Predicate Devices

• Liverpool Radial Head Replacement Device (K012551)
• Radial Head Surface Replacement (Implex Corp. K984290)
• Radial Head Implant (Avanta Orthop., Inc., K002644)
• Modular Radial Head (Wright Medical Tech. Inc., K991915)

Submission Summary (Full Text)

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K040611

JUN 0 4 2004

**BIOMET**

## Summary of Safety and Effectiveness

Biomet Manufacturing Corp. Applicant/Sponsor: 56 Bell East Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Contact Person: Patricia Sandborn Beres Telephone: [phone]

Proprietary Name: Modular 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: Liverpool Radial Head Replacement Device (K012551), Radial Head Surface Replacement (Implex Corp. K984290), Radial Head Implant (Avanta Orthop., Inc., K002644) and Modular Radial Head (Wright Medical Tech. Inc., K991915)

Device Description: The Modular Radial Head Replacement Device is a two-piece prosthesis consisting of a stem (Ti-6Al-4V) and a head (Co-Cr-Mo). The tapered stem is cemented into the intramedullary canal of the radius. The head has a highly polished concave surface to articulate with the natural bone of the humerus and ulna. The proximal portion of the stems are roughened with a Bond Coat surface. The components connect via a dove-tail joint secured by a locking screw. The device is available in three diameters, 18mm, 20mm and 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.

Intended Use: The Modular 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.

Summary of Technologies: The technological characteristics (materials, design, sizing, and indications) of the Modular 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 PO. Box 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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()FFICE 574.267.6639

FAX [phone]

E MAII. [e-mail]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 0 4 2004

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K040611

Trade/Device Name: Modular Radial Head Replacement Device Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Codc: KWI Dated: March 5, 2004 Received: March 8, 2004

Dear Ms. Sandborn Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviously of a became in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use mated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conner of the reserved 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 r ou may, diererery mains 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to basil advanced 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 I fease of actived a determination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must of any i edotar statutes and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set orth 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.

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## Page 2 - Ms. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher wif anow you're ough finding of substantial equivalence of your device to a legally prematication. The PDF Amazingssification 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), please If you desire specific acrioliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Melkerson

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

Enclosure

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## Indications for Use

510(k) Number (if known):

Modular Radial Head Replacement Device Device Name:

Indications For Use: The Modular 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
- Resistance to conservative treatment b)
- 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.

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

Over-The-Counter Use (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)

Mark H. Millheim

Division of General, Restorative, and Neurological Devices

KO40611 510(k) Number.

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