ASCENSION MODULAR RADIAL HEAD

K032686 · Ascension Orthopedics, Inc. · KWI · Oct 22, 2003 · Orthopedic

Device Facts

• Record ID: K032686
• Device Name: ASCENSION MODULAR RADIAL HEAD
• Applicant: Ascension Orthopedics, Inc.
• Product Code: KWI · Orthopedic
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ascension® Modular Radial Head is intended 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: - joint destruction or subluxation visible on x-ray - 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

Ascension® Modular Radial Head is an anatomically designed, single-use, modular prosthesis for proximal radius replacement. Device consists of head and stem components in multiple sizes, assembled via taper connection. Used by orthopedic surgeons in clinical settings to treat radial head fractures, degenerative/post-traumatic disabilities, or failed prior arthroplasty. Prosthesis restores joint function, reduces pain, and improves motion at radio-humeral and proximal radio-ulnar joints.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: ASTM F1537 cobalt chromium alloy. Design: Modular, anatomically shaped radial head prosthesis with taper connection. Components: 6 head sizes, 4 stem sizes. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring radial head replacement due to degenerative or post-traumatic disabilities (pain, crepitation, decreased motion at radio-humeral/proximal radio-ulnar joints with radiographic joint destruction/subluxation and resistance to conservative treatment), primary fracture, symptomatic sequelae post-resection, or revision of failed 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

• Avanta Orthopaedics, Inc., Radial Head Implant (K982288)
• Wright Medical Technology, Inc., Modular Radial Head (K991915)

Submission Summary (Full Text)

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# OCT 2 2 2003 1

#### Page 31 of 157

### 510(k) SUMMARY

63,268

| SUBMITTER NAME: | Ascension Orthopedics, Inc.<br>8200 Cameron Road, C-140<br>Austin, TX 78754-3832 |
|-----------------|----------------------------------------------------------------------------------|
| 510(k) CONTACT: | Peter Strzepa<br>Phone: [phone] |
| TRADE NAME: | Ascension® Modular Radial Head |
| COMMON NAME: | radial head prosthesis |
| CLASSIFICATION: | 21 CFR §888.3170 |
| PRODUCT CODE: | 87 KWI |
| PANEL: | Orthopedic and Rehabilitation Device |

#### PREDICATE DEVICE:

Avanta Orthopaedics, Inc., Radial Head Implant (K982288) Wright Medical Technology, Inc., Modular Radial Head (K991915)

#### DEVICE DESCRIPTION:

The Ascension® Modular Radial Head is an anatomically designed, single-use, modular prosthesis designed for replacement of the proximal end of the radius. It is made from ASTM F1537 cobalt chromium alloy. Head components available in six sizes and stem components available in four sizes are interchangeable and achieve assembly by means of a taper connection.

#### INTENDED USE:

The Ascension® Modular Radial Head is intended for:

- e 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:
- o joint destruction or subluxation visible on x-ray
- o resistance to conservative treatment
- Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection .
- . Revision following failed radial head arthroplasty

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

A comparison of materials and design features, as well as performance tests and analyses, demonstrate that the Ascension® Modular Radial Head is substantially equivalent to the predicate devices.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

Mr. Peter Strzepa Vice President. Science and Technology Ascension Orthopedics, Inc. 8200 Cameron Road, C-140 Austin, TX 78754-3832

Re: K032686

Trade/Device Name: Ascension® Modular Radial Head Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: August 29, 2003 Received: August 29, 2003

Dear Mr. Strzepa:

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 (OS) 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 - Mr. Peter Strzepa

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/dsmaldsmamain.html

Sincerely yours,

Sincerely yours,

Mark N Millman

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:

K82686

032686

Device Name:

Ascension® Modular Radial Head

Indications for Use:

The Ascension® Modular Radial Head is intended for:

- Replacement of the radial head for degenerative or post-traumatic disabilities o presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray
- o 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 NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Mark N. Millman

10(k) Number K03268

Over-The-Counter Use _

(Optional Format 1-2-96)