DISTAL RADIO-ULNAR JOINT IMPLANT

K053119 · Aptis Medical, LLC · KXE · Dec 7, 2005 · Orthopedic

Device Facts

• Record ID: K053119
• Device Name: DISTAL RADIO-ULNAR JOINT IMPLANT
• Applicant: Aptis Medical, LLC
• Product Code: KXE · Orthopedic
• Decision Date: Dec 7, 2005
• Decision: SESE
• Submission Type: Special
• 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 radioulnar joint (DRUJ) prosthesis; replaces distal ulnar head. Implant consists of body and stem components; fixed via intramedullary canal placement and screw fixation to distal radius. Semi-constrained design. Used by orthopedic surgeons in clinical settings for patients with arthritis, instability, or failed prior resections. Provides structural replacement to restore joint function; alleviates pain and weakness associated with DRUJ pathology.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to the predicate device.

Technological Characteristics

Materials: Cobalt-Chromium (Co-Cr), Ultra-High-Molecular-Weight Polyethylene (UHMWPe), Commercially Pure Titanium (CPTi). Design: Semi-constrained distal ulnar head prosthesis. Fixation: Intramedullary stem and screw fixation to distal radius. Single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring distal radioulnar joint replacement following ulnar head resection arthroplasty due to rheumatoid, degenerative, or post-traumatic arthritis, failed prior resection (e.g., Darrach), primary fracture of the ulnar head/neck, or revision of failed arthroplasty. Patients must present with wrist pain/weakness unresponsive to non-operative treatment and radiographic evidence of ulnar head instability, dislocation, or erosive changes.

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

• Aptis Medical Distal Radio-Ulnar Joint Implant (K053119)

Submission Summary (Full Text)

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K053119 p1/3

## 510 (k) Summary

#### 2005 DEC 7

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

| Prepared: | October 27, 2005 |
|------------|----------------------|
| Applicant: | Aptis Medical, LLC |
| | 5 River Hill Road |
| | Louisville, KY 40207 |
| Telephone | 502-899-3974 |
| Fax | 502-897-9007 |

Device Name: Device Trade Name: Device Classification: Reviewing Panel: Regulation Number Product Code: Original Predicate Device: Registration Number: Owner Operator Number:

Wrist joint ulnar (hemi-wrist) prosthesis Distal Radio-Ulnar Joint Implant Class II Orthopedic 888.3810 87 KXE Distal Radio-Ulnar Joint Implant 3004521401 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

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K053119 p2/3

- Failed ulnar head resection; eg. Darrach resection .
- Primary replacement after fracture of the ulnar head or neck. .
- Revision following failed ulnar head arthroplasty. .

Comparison to the Original Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the same device, the Aptis Medical Distal Radio-Ulnar Joint Implant

II Regulatory Class: 87 KXE Product Code:

Comparison of original Aptis Medical Distal Radioulnar Joint to the new configuration the additional stem lengths and diameters.

| Item | Original Aptis Product | Proposed additional size |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Distal Radioulnar Joint | Distal Radioulnar Joint |
| | Implant | Implant |
| Use | Single use | Single use |
| Fixation | stem in intramedulary canal, | stem in intramedulary canal, |
| | screw fixation to the distal | screw fixation to the distal |
| | radius | radius |
| Constraint | Semi constrained | Semi constrained |
| Material | Co-Cr, UHMWPe, CPTi | Co-Cr, UHMWPe, CPTi |
| Sizes | 2 sizes, 20, 30 body and | 2 sizes, 20, 30, body |
| | stem | 25 size stems |
| Indications for use | Aptis Medical Distal Radio Ulnar<br>Head implant is intended for<br>replacement of the distal radioulnar<br>joint following ulnar head<br>resection arthroplasty: | Aptis Medical Distal Radio Ulnar<br>Head implant is intended for<br>replacement of the distal radioulnar<br>joint following ulnar head<br>resection arthroplasty: |
| | Replacement of the distal ulnar<br>head for rheumatoid, degenerative,<br>or post-traumatic arthritis<br>presenting with the following<br>findings: | Replacement of the distal ulnar<br>head for rheumatoid, degenerative,<br>or post-traumatic arthritis<br>presenting with the following<br>findings: |
| | Pain and weakness of the wrist<br>joint not improved by non-<br>operative treatment | Pain and weakness of the wrist<br>joint not improved by non-<br>operative treatment |
| | Instability of the ulnar head with<br>radiographic evidence of<br>dislocation or erosive changes of<br>the distal radioulnar joint | Instability of the ulnar head with<br>radiographic evidence of<br>dislocation or erosive changes of<br>the distal radioulnar joint |
| | Failed ulnar head resection; eg.<br>Darrach resection | Failed ulnar head resection; eg.<br>Darrach resection |
| | Primary replacement after fracture<br>of the ulnar head or neck. | Primary replacement after fracture<br>of the ulnar head or neck. |

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K053119 p³/₃

Revision following failed ulnar head arthroplasty.

Revision following failed ulnar head arthroplasty.

Similarities of the Aptis Medical DRUJ and the Aptis Medical DRUJ additional length and diameter stems include;

Both devices are intended for single use only; Both devices are intended for surgical implantation longer than 30 days; Both devices are placed into the intramedullary canal of the distal ulna; Both devices are made of the same industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the identical indications for use.

Summary:

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

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DEC 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bryan Babb Aptis Medical, LLC. 5 River Hill Road Louisville, Kentucky 40207

Re: K053119

Trade/Device Name: Distal Radio-Ulnar Joint Implant (DRUJ) Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE Dated: October 27, 2005 Received: November 7, 2005

Dear Mr. Babb:

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 Cossmetic 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 elcctronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Bryan Babb

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oogh manieting your and equivalence of your device to a legally premarket notheation: "The PDA maing of castion 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 If you desire specific at not 10-1 at [phone]. Also, please note the regulation entitled, Contact the Oriece of Commarket notification" (21CFR Part 807.97). You may obtain Misoranung Uy releveloe to premanton on your responsibilities under the Act from the Division of Small other general information of your copsumer Assistance at its toll-free number [phone] or 1011) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Millman

Mark N. Melkerson Acting 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 (if known): Device Name: Distal Radio Ulnar Head 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 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. .

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

Mark A. Milliken

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number