ACUMED ANATOMIC RADIAL HEAD SYSTEM

K041858 · Acumed, LLC · KWI · Oct 5, 2004 · Orthopedic

Device Facts

• Record ID: K041858
• Device Name: ACUMED ANATOMIC RADIAL HEAD SYSTEM
• Applicant: Acumed, LLC
• Product Code: KWI · Orthopedic
• Decision Date: Oct 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acumed Anatomic Radial Head System is indicated for use in: 1. 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 and/or subluxation, 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

Device Story

Acumed Anatomic Radial Head System; modular radial head prosthesis; replaces proximal radius; restores articulation with radial notch of ulna and capitulum of distal humerus. Used by orthopedic surgeons in clinical settings for patients with degenerative/post-traumatic joint disabilities or fractures. Device consists of modular heads and stems. Provides anatomical replacement to alleviate pain and restore joint motion. Benefits include improved joint function and stability following trauma or degenerative disease.

Clinical Evidence

No clinical data provided; assessment of performance data and clinical/non-clinical tests stated as not applicable.

Technological Characteristics

Modular radial head prosthesis. Materials: Cobalt alloy head (ASTM F1537), titanium alloy stem (ASTM F136). Elliptical shape. Highly polished surface. 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), primary radial head fractures, 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 Radial Head Implant (K002644)
• Wright Medical Inc. Modular Radial Head (K991915)

Submission Summary (Full Text)

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K 041858

5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432

Tel [phone]

## 510(k) Summary

This sunmary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Submitter Information: Acumed LLC |
|------------------------------------------------------------|
| 5885 N.W. Cornelius Pass Road |
| Hillsboro, OR 97124-9432 |
| USA |
| Phone: [phone] |
| FAX: [phone] |
| Contact: Ed Boehmer, Regulatory & Documentation Supervisor |

| Classification Name: | Prosthesis, Elbow, Hemi-, Radial, Polymer |
|----------------------------------------|---------------------------------------------------------------------------------------|
| Common Name: | Elbow Hemi-, Prosthesis |
| Proprietary Name: | Acumed Anatomic Radial Head System |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3170 |
| Device Product Code: | KWI |
| Legally Marketed Equivalent Device(s): | Avanta Radial Head Implant K002644<br>Wright Medical Inc. Modular Radial Head K991915 |

Device Description: The Acumed Anatomic Radial Head System includes modular heads and stems with accessories to anatomically replace the proximal potion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.

Intended Use: The Acumed Anatomic Radial Head System is indicated for use in:

- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, l . crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, 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

These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.

Technological Characteristics: The Acumed Anatomic Radial Head System uses an elliptically shaped, highly polished cobalt alloy head (ASTM F1537) with a titanium alloy stem (ASTM F136). Both cobalt alloy and titanium alloy have been successfully used in numerous implant prostheses. There are no technological characteristics that raise new issues of safety or effectiveness.

An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.

Based upon the similarities of the Acumed Anatomic Radial Head System and the predicate devices studied, the safety and effectiveness of the Acumed Anatomic Radial Head System is substantially equivalent to the predicate devices referenced.

> Acumed LLC Page 51

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 - 2004

Mr. Ed Boehmer Regulatory and Documentation Supervisor Acumed, LLC 5885 N.W. Cornelius Pass Road Hillsboro, Oregon 97124-9432

Re: K041858

Trade/Device Name: Acumed Anatomic Radial Head System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: July 8, 2004 Received: July 9, 2004

Dear Mr. Boehmer:

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 – Mr. Ed Boehmer

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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark A. Millerson

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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| 510(k) Number (if known): | K041858 |
|---------------------------|---------|
|---------------------------|---------|

Acumed Anatomic Radial Head System Device Name: __

Indications For Use:

The Acumed Anatomic Radial Head System and accessories are designed specifically for:

- 1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, 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

Prescription Use
(Part 21 CFR 801 Subpart D) X

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 N Millner

I Restorative. Division of Ge and Neurological De

**510(k) Number** K041858