MODULAR RADIAL HEAD

K991915 · Wrightmedicaltechnologyinc · KWI · Sep 3, 1999 · Orthopedic

Device Facts

• Record ID: K991915
• Device Name: MODULAR RADIAL HEAD
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWI · Orthopedic
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use of the Modular Radial Head Implants may be considered for : Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: a. joint destruction and/or subluxation visible on x-ray; and/or b. resistance to conservative treatment. Primary replacement after fracture of the radial head. Symptomatic sequelae after radial head resection. Revision following failed radial head arthroplasty.

Device Story

Modular Radial Head is a two-piece metallic prosthesis; manufactured from Cobalt Chrome (ASTM F 1537). Device consists of a head and stem assembled at time of implantation; available in standard sizes plus +2 and +4 configurations. Intended for surgical replacement of radial head in radio-humeral or proximal radio-ulnar joints. Operated by orthopedic surgeons in clinical/hospital settings. Provides structural replacement to restore joint function, alleviate pain, and address post-traumatic or degenerative conditions. Clinical benefit derived from mechanical restoration of joint anatomy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Cobalt Chrome (ASTM F 1537). Design: Two-piece modular radial head prosthesis. Configurations: Standard, +2, and +4 sizes. Proximal head: concave with rounded contours. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring radial head replacement due to degenerative or post-traumatic disabilities (pain, crepitation, decreased motion) with joint destruction/subluxation or resistance to conservative treatment, primary replacement after radial head fracture, symptomatic sequelae post-resection, or revision of failed radial head arthroplasty.

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

• Metallic Radial Head Implant

Submission Summary (Full Text)

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SEP 13 1999

Attachment 2

Summary

K991915

510(k) Summary

Company: Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002

Date: June 7, 1999 Trade Name: Modular Radial Head Common Name: Radial Head Prosthesis Predicate Device: Metallic Radial Head Implant

## Description/Intended Use:

The Modular Radial Head is manufactured from Cobalt Chrome (ASTM F 1537) . The stem is designed to be a two-piece modular design that is assembled at the time of implantation. The proximal portion of the head is concave and has rounded contours. The head and stem are available in standard sizes and +2 and +4 configurations.

Use of the Modular Radial Head Implants may be considered for :

- Replacement of the radial head for degenerative or post-traumatic ● disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- a. joint destruction and/or subluxation visible on x-ray; and/or b. resistance to conservative treatment.
- Primary replacement after fracture of the radial head. .
- Symptomatic sequelae after radial head resection. .
- Revision following failed radial head arthroplasty. .

The Modular Radial Head was declared substantially equivalent to the predicate devices. Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 1999

Ms. Lynne Witkowski Regulatory Affairs Associate Wright Medical Technology Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K991915 Trade Name: Modular Radial Head Regulatory Class: II Product Code: KWI Dated: June 4, 1999 Received: June 7, 1999

Dear Ms. Witkowski:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Ms. Lynne Witkowski

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colin M. Witter, Ph.D., M.D.

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

Enclosure

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| Attachment 3 | Indications for Use Statement |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number<br>(if known) | K991915 |
| Device Name | Modular Radial Head |
| Indications for Use | Intended Use<br>Use of the Modular Radial Head Implants may be considered for : <ul><li>Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: <ol><li>joint destruction and/or subluxation visible on x-ray; and/or</li><li>resistance to conservative treatment.</li></ol></li><li>Primary replacement after fracture of the radial head.</li><li>Symptomatic sequelae after radial head resection.</li><li>Revision following failed radial head arthroplasty.</li></ul> |

Revision following failed radial head arthroplasty. .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (per 21 CFR 801.109)

OR

Over-The Counter Use

P cóll

(Division Sigh-Off) Division of General Restorative Devices 510(k) Number -