DISTAL RADIO-ULNAR JOINT IMPLANT

K040497 · Aptis Medical, LLC · KXE · Jan 26, 2005 · Orthopedic

Device Facts

• Record ID: K040497
• Device Name: DISTAL RADIO-ULNAR JOINT IMPLANT
• Applicant: Aptis Medical, LLC
• Product Code: KXE · Orthopedic
• Decision Date: Jan 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings: Pain and weakness of the wrist joint not improved by non-operative treatment Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint Failed ulnar head resection; eg. Darrach resection Primary replacement after fracture of the ulnar head or neck. Revision following failed ulnar head arthroplasty.

Device Story

Distal Radio-Ulnar Joint Implant replaces distal ulnar head; indicated for arthritis, instability, or failed prior resection. Device features semi-constrained design; utilizes intramedullary stem fixation in distal ulna and screw fixation to distal radius. Implanted by orthopedic surgeons in clinical/surgical settings. Provides structural joint replacement to restore function and reduce pain. Materials include Co-Cr, UHMWPe, and CPTi. Device is single-use.

Clinical Evidence

No clinical data provided; substantial equivalence based on design characteristics and intended use comparison to predicate.

Technological Characteristics

Materials: Co-Cr, UHMWPe, CPTi. Fixation: Intramedullary stem and screw fixation to distal radius. Design: Semi-constrained distal radioulnar joint prosthesis. Form factor: 2 sizes. Single-use.

Indications for Use

Indicated for patients requiring distal radioulnar joint replacement due to rheumatoid, degenerative, or post-traumatic arthritis with pain, weakness, or instability; failed prior ulnar head resection (e.g., Darrach); ulnar head/neck fractures; or revision of failed ulnar head arthroplasty.

Regulatory Classification

Identification

A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.

Predicate Devices

• WMT Modular Ulnar Head, Wright Medical Technology, Inc.

Submission Summary (Full Text)

{0}------------------------------------------------

## JAN 2 6 2005

#### 510 (k) Summary

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

February 25, 2004 Prepared:

Applicant: Aptis Medical, LLC 5 River Hill Road Louisville, KY 40207

| Device Name: | Wrist joint ulnar (hemi-wrist) prosthesis |
|------------------------|------------------------------------------------------------|
| Device Trade Name: | Distal Radio-Ulnar Joint Implant |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3810 |
| Product Code: | 87 KXE |
| Predicate Device: | WMT Modular Ulnar Head, Wright<br>Medical Technology, Inc. |

#### Owner Operator Number:

9054354

Device Description:

The ulnar head implant like the predicate device includes various sizes of implants and surgical instruments. The implant allows for replacement of the distal ulnar head.

### Indications for Use:

Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:

- Replacement of the distal ulnar head for rheumatoid, degenerative, or post-. traumatic arthritis presenting with the following findings:
- . Pain and weakness of the wrist joint not improved by non-operative treatment
- Instability of the ulnar head with radiographic evidence of dislocation . or erosive changes of the distal radioulnar joint
- . Failed ulnar head resection; eg. Darrach resection

{1}------------------------------------------------

- Primary replacement after fracture of the ulnar head or neck. ●
- Revision following failed ulnar head arthroplasty. .

Comparison to Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Wright Medical Technologies Modular Ulnar Head Implant.

Regulatory Class: II Product Code: 87 KXE

| Item | Aptis Product | Wright Medical Technologies |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Distal Radioulnar Joint Implant | WMT Modular Ulnar Head Implant |
| Use | Single use | Single use |
| Fixation | stem in intramedulary canal, screw fixation to the distal radius | stem in intramedulary canal |
| Constraint | Semi constrained | non constrained |
| Material | Co-Cr, UHMWPe, CPTi | Co-Cr, Titanium Alloy, Plasma Spray |
| Sizes | 2 sizes, 1, 2 | 8 heads, 6 stems |
| Indications for use | Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:<br>Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:<br>Pain and weakness of the wrist joint not improved by non-operative treatment<br>Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint<br>Failed ulnar head resection; eg. Darrach resection<br>Primary replacement after fracture of the ulnar head or neck.<br>Revision following failed ulnar head arthroplasty | WMT Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:<br>Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting with the following findings:<br>Pain and weakness of the wrist joint not improved by non-operative treatment<br>Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint<br>Failed ulnar head resection; eg. Darrach resection<br>Primary replacement after fracture of the ulnar head or neck.<br>Revision following failed ulnar head arthroplasty |

Table 1. Comparison of Aptis and WMT ulnar head.

Similarities of the Aptis Medical, LLC and WMT Modular Ulnar Head Implant include:

{2}------------------------------------------------

Both devices are: intended for single use only; intended for surgical implantation longer than 30 days; placed into the intramedullary canal of the distal ulna; made of industry standard materials; comparable in size; and have the same indications for use.

Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2005

Aptis Medical, LLC C/o Ms. Louise M. Focht P.O. Box 249 Del Mar, California 92014

Re: K040497

Trade/Device Name: Distal Radio-Ulnar Joint Implant Regulation Numbers: 21 CFR 888.3810 Regulation Names: Wrist joint ulnar (hemi-wrist) polymer prosthesis Product Code: KXE Dated: November 22, 2004 Received: November 23, 2004

Dear Ms. Focht:

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.

{4}------------------------------------------------

Page 2 – Ms. Louise M. Focht

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,

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

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known): K040497, Device Name: Distal Radio-Ulnar Joint Implant Indications for Use:

Aptis Medical Distal Radio Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:

- Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic . arthritis presenting with the following findings:
- Pain and weakness of the wrist joint not improved by non-operative treatment .
- Instability of the ulnar head with radiographic evidence of dislocation or erosive . changes of the distal radiouinar joint
- Failed ulnar head resection; eg. Darrach resection .
- Primary replacement after fracture of the ulnar head or neck. .
- Revision following failed ulnar head arthroplasty. .

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Mark A. Millhause

Division of General, Restorative, and Neurological Devices

Page of

K040497 510(k) Number_