EVOLVE MODULAR RADIAL HEAD

K060731 · Wrightmedicaltechnologyinc · KWI · Apr 19, 2006 · Orthopedic

Device Facts

• Record ID: K060731
• Device Name: EVOLVE MODULAR RADIAL HEAD
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWI · Orthopedic
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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® Modular Radial Head is a prosthetic implant system designed for surgical replacement of the radial head. The system consists of modular stems and heads used to restore joint function in the elbow. It is intended for use by orthopedic surgeons in a clinical/hospital setting. The device replaces damaged or fractured bone, aiming to alleviate pain and restore motion at the radio-humeral and proximal radio-ulnar joints. This submission expands the existing product line to include additional sizes of stems and heads, maintaining the same design features and operational principles as the predicate device.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by materials data and bench testing results.

Technological Characteristics

Modular radial head and stem prosthesis. Design features and materials are identical to the predicate device (K991915). Class II polymer prosthesis per 21 CFR 888.3170.

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, 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)

Submission Summary (Full Text)

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APR 1 9 2006

Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in large, bold, sans-serif font. Below the word is a graphic of three arrows pointing to the right. Underneath the arrows is the alphanumeric code "K060731" in a handwritten style font.

## 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® Modular Radial Head.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------------------------------|
| Date: | March 17, 2006 |
| Contact Person: | Wesley L. Reed |
| | Regulatory Affairs Specialist II |
| Proprietary Name: | EVOLVE® Modular Radial Head |
| Common Name: | Modular Radial Head |
| Classification Name and Reference: | 21 CFR 888.3170 Elbow joint radial (hemi elbow) polymer prosthesis – Class II |
| Device Product Code and Panel Code: | Orthpedics/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. .

#### B. DEVICE DESCRIPTION

The EVOLVE® Modular Radial Head Implant System is being extended to include additional size stems and heads. The design features of these additional sizes are identical to the previously submitted and cleared stems and heads under 510(k); K991915- EVOLVE® Modular Radial Head.

#### headquarters

Wright Medical Technology, Inc.

5677 Airline Road

Arlington, TN 38002

901.867.9971 pho

www.wmt.com

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada
011.81.3.3538.0474 Japan

011.33.1.45.13.24.40 France 011.44.1483.721.404 UK

1.49.4161.745130 Germany

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### C. SUBSTANTIAL EQUIVALENCE INFORMATION

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2006

Wright Medical Technologies, Inc. c/o Mr. Wesley L. Reed Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K060731

Trade/Device Name: EVOLVE Modular Radial Head Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: Class II Product Code: KWI Dated: March : 7, 2006 Received: March 20, 2006

Dear Mr. Reed:

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 CTR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set

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Page 2 - Mr. Wesley L. Reed

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. 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 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/industry/support/index.html.

Sincerely yours,

Herbert Leonard

Mark N. Melkerson 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

K060731 510(k) Number (if known):

Device Name: EVOLVE® Modular Radial Head

Indications For 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. .

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)

Huler Lemusica

1 of 1

(Division SELECT == C == 1 Division of General, Restorativ. and Neurological Devices

510(k) Number K100731