EVOLVE CERAMIC RADIAL HEAD IMPLANT

K030384 · Wrightmedicaltechnologyinc · KWI · Aug 12, 2003 · Orthopedic

Device Facts

• Record ID: K030384
• Device Name: EVOLVE CERAMIC RADIAL HEAD IMPLANT
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWI · Orthopedic
• Decision Date: Aug 12, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use of the Modular Radial Head Implant 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

EVOLVE® Ceramic Radial Head Implant is a prosthetic device for radial head replacement; intended for use in orthopedic surgery. Device features a concave proximal surface to approximate natural anatomy and a radius of curvature on sides for articulation with the proximal radial-ulnar joint. Heads are available in 2.0mm increments (20.0mm to 28.0mm diameter). Device is designed to be used with previously cleared CoCr stem components. Implant provides stability to the bearing surface; replaces damaged radial head to restore joint function and reduce pain. Operated by orthopedic surgeons in clinical/surgical settings.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and materials data.

Technological Characteristics

Ceramic radial head implant; concave proximal design; 20.0mm to 28.0mm diameter range in 2.0mm increments. Modular design for use with CoCr stems. Sterilization method utilized. No software or electronic components.

Indications for Use

Indicated for patients requiring radial head replacement due to degenerative or post-traumatic disabilities (pain, crepitation, decreased motion, 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

• EVOLVE® Modular Radial Head (K991915)
• ORTHOSPHERE® Ceramic Spherical CMC Implant (K960659)

Submission Summary (Full Text)

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AUG 1 2 2003

K030384 Pa

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### A Wright Medical Group Company 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLVE® Ceramic Radial Head Implant.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------------------------|
| Date: | February 3, 2003 |
| Contact Person: | Jeanine H. Redden<br>Regulatory Affairs Associate |
| Proprietary Name: | EVOLVE® Ceramic Radial Head Implant |
| Common Name: | RADIAL HEAD PROSTHESIS |
| Classification Name and Reference: | 21 CFR 888.3170 Prosthesis, Elbow, Hemi-, Radial,<br>Polymer - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ KWI |

# DEVICE INFORMATION

#### A. INTENDED USE

Use of the Modular Radial Head Implant 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. ●

### C. DEVICE DESCRIPTION

The EVOLVE® Ceramic Radial Head Implant is identical to the head component previously submitted and cleared under 510(k): K991915- EVOLVE® Modular Radial Head. The only difference between the two devices is the type of materials used to

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K010384 P090 *42

Special 510(k) EVOLVE® Ceramic Radial Head Implant 510(K) SUMMARY Page 2 of 2

> manufacture the head components. The EVOLVE® Modular Radial Head system is approved with a CoCr head component, and a CoCr stem component. Wright Medical Technology is now adding a ceramic head component for use with the CoCr stem component previously cleared under the EVOLVE® Modular Radial Head (510(k): K991915).

The design features for both EVOLVE® radial head components are as follows:

- The proximal portion of the radial head will have a concave design to provide . stability to the bearing surface and closely approximate the natural anatomy of the radial head and humeral-capitellum articulating surface.
- The sides of the head are designed with a radius of curvature that articulates with the . proximal radial-ulnar joint and closely approximates the natural anatomy.
- The heads are interchangeable, since the interface has the same dimensions ● throughout the system.
- Heads are available in 2.0mm increments, ranging from 20.0mm to 28.0mm in . diameter.

#### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, type of interface, operating principles, shelf life, and design features of the EVOLVE® Ceramic Radial Head Implant are substantially equivalent to the head component covered under the EVOLVE® Modular Radial Head (510(k): K991915). The sterilization process and material used to manufacture the EVOLVE® Ceramic Radial Head Implant is substantially equivalent to the ORTHOSPHERE® Ceramic Spherical CMC Implant - 510(k): K960659. Additionally, the safety and effectiveness of the EVOLVE® Ceramic Radial Head Implant is adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification.

Image /page/1/Picture/10 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, serif typeface. Below the word "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2003

Ms. Jeanine H. Redden Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002

Re: K030384

Trade/Device Name: EVOLVE® Ceramic Radial Head Implant Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: July 17, 2003 Received: July 18, 2003

Dear Ms. Redden:

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.

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.

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); good manufacturing practice requirements as set forth 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. Jeanine H. Redden

This letter will allow you to begin marketing your device as described in your Section 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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 may be obtained from the Division of Small Manufacturers, International 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,

Clay Witt

Colie M. Witton, Ph.D., M.

ia 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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K03.384

Image /page/4/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other on the right. The "W" is made up of three thick, black, angled lines, and the words are in a simple, sans-serif font.

A Wright Medical Group Company

# EVOLVE® Ceramic Radial Head Implant

### INDICATIONS STATEMENT

#### Use of the Modular Radial Head Implant 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

ision Sign-Off Division of General Restorativ 510(k) Number

> Over-The Counter Use No (Optional Format 1-2-96)

Prescription Use (Per21 CFR 801.199

OR

Image /page/4/Picture/18 description: The image shows the logo for Wright Medical Technology. The logo consists of a large, stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company".

5 6 7 7 Airline Road Arlington, Tennessee 38002 r 901 - 8 6 7 - 9 9 7 1