ASCENSION MUH

K052137 · Ascension Orthopedics, Inc. · KXE · Nov 3, 2005 · Orthopedic

Device Facts

• Record ID: K052137
• Device Name: ASCENSION MUH
• Applicant: Ascension Orthopedics, Inc.
• Product Code: KXE · Orthopedic
• Decision Date: Nov 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ascension® MUH implant is intended for replacement of the distal radioulnar joint: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting the following: - Pain and weakness of the wrist joint not improved by conservative treatment - Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes - Failed ulnar head resection .

Device Story

Ascension® MUH is a single-use, two-component modular ulnar head prosthesis. It replaces the distal ulnar head in the distal radioulnar joint. The device consists of a head and stem assembled via a taper connection and implanted into the intramedullary canal of the ulna. It is used by orthopedic surgeons in a clinical/surgical setting. The prosthesis provides a hemi-articulation to restore joint function, alleviate pain, and address instability caused by arthritis or failed prior resection. It benefits patients by restoring wrist stability and function.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional comparison to the predicate device.

Technological Characteristics

Modular two-piece prosthesis. Head: Cobalt chromium alloy (ASTM F1537). Stem: Titanium Ti6Al4V ELI (ASTM F136). Fixation: Intramedullary canal. Assembly: Taper connection. Articulation: Hemi. Surface finish: Roughened. Single-use. Non-sterile instrumentation available separately.

Indications for Use

Indicated for patients requiring distal radioulnar joint replacement due to rheumatoid, degenerative, or post-traumatic arthritis with wrist pain/weakness, ulnar head instability with dorsal subluxation/erosive changes, or failed ulnar head resection. Contraindicated in patients with malunited forearm fractures, inadequate soft tissue support, insufficient skin/musculotendinous coverage, open epiphyses, history of infection/open fracture, or material sensitivity.

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

• Avanta Orthopaedics, Inc., Ulnar Head Implant (K010786)

Submission Summary (Full Text)

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K052137 p½
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# 510(k) SUMMARY

| SUBMITTER NAME: | Ascension Orthopedics, Inc.<br>8700 Cameron Road, C-100<br>Austin, TX 78754-3832 |
|-----------------|----------------------------------------------------------------------------------|
| 510(k) CONTACT: | Glen Neally<br>Phone: [phone] |
| TRADE NAME: | Ascension® MUH |
| COMMON NAME: | ulnar head prosthesis |
| CLASSIFICATION: | 21 CFR §888.3810 |
| PRODUCT CODE: | 87 KXE |
| PANEL: | Orthopedic |

#### PREDICATE DEVICE:

Avanta Orthopaedics, Inc., Ulnar Head Implant (K010786)

## DEVICE DESCRIPTION:

The Ascension® MUH implant is a single-use, two-component, modular prosthesis designed for replacement of the ulnar head. Components will be available in three head sizes, and nine stem sizes which are assembled by means of a taper connection. Device components are made from cobalt chromium alloy meeting ASTM F1537 and titanium Ti6A14V ELI meeting ASTM F136, the same materials used to fabricate other ulnar head prostheses that have market clearance for sale in the United States.

## INTENDED USE:

The Ascension® MUH implant is intended for replacement of the distal radioulnar joint:

Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting the following:

- . Pain and weakness of the wrist joint not improved by conservative treatment
- Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive . changes
- Failed ulnar head resection .

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

A comparison of identical materials and nearly identical design features, demonstrate that the Ascension® MUH is substantially equivalent to the predicate device as indicated in the chart below:

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| Comparison<br>Feature | Ascension Modular Ulnar Head | Avanta Ulnar Head Implant |
|--------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Design | Two-piece modular implant | Two-piece modular implant |
| Material (Head) | ASTM F1537 cobalt chromium | ASTM F1537 cobalt chromium |
| Material (Stem) | ASTM F136 Ti6Al4V ELI | CpTi |
| Assembly | Taper connection | Taper connection |
| Fixation | Stem in medullary canal | Stem in medullary canal |
| Articulation | Hemi | Hemi |
| Use | Single use only, surgical implantation longer than 30 days | Single use only, surgical implantation longer than 30 days |
| Sterilization by<br>user | Resterilization of device is not recommended. | Resterilization of device is not recommended. |
| Packaging | Double barrier assembly in paperboard box | Double barrier assembly in paperboard box |
| Accessories | Sterilizable instrumentation is available separately (not provided sterile). | Sterilizable instrumentation is available separately (not provided sterile). |
| Stem surface<br>finish | Roughened | Roughened |
| Available sizes | Three heads:<br>(3 diameters)<br>Nine stems | Three heads:<br>(3 diameters)<br>Six stems |

Similarities of the Ascension® MUH implant and the Avanta Ulnar Head Implant include: Both devices have the same indications for use; Both devices are made of the same industry standard materials; No new materials are introduced in either product; Both devices are placed into the intramedullary canal of the distal end of the ulna; Both devices are a hemi articulation; Both devices are intended for surgical implantation longer than 30 days: Both devices are intended for single use only.

#### Summary:

The Ascension® MUH is functionally identical, comparably sized, and has a similar design as compared to the Avanta Ulnar Head Implant. Individual components for the subject and predicate device are provided sterile in individual packages. The Ascension® MUH shares identical indications for use with the predicate device, and is fabricated from the same material as the predicate device. Therefore, the Ascension® MUH is substantially equivalent to the predicate device.

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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 features a stylized depiction of an eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2005

Glen Neally Director of QA/RA Ascension Orthopedics, Inc. 8700 Cameron Road, Suite 100 Austin, Texas 78754-3832

Re: K052137

Trade/Device Name: Ascension® MUH Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE Dated: July 22, 2005 Received: August 5, 2005

Dear Mr. Neally:

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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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.

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: K052137

Ascension® MUH Device Name:

#### Indications for Use:

The Ascension® MUH is intended for replacement of the distal radioulnar joint:

Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting the following:

- Pain and weakness of the wrist joint not improved by conservative treatment .
- Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive . changes
- Failed ulnar head resection .

Contraindications

- Malunited forearm fractures that preclude stabalization of the ulnar head during . pronation/supination
- . Tendon, ligament, or distal radioulnar joint which cannot provide adequate support or fixation for the prostheses
- Inadequate skin or musculotendinous system .
- Growing patients with open epiphyses .
- Previous open fracture or infection in or around the joint . Known sensitivity to materials used in this device

X Prescription Use (Part 21 CFR 801Subpart B) Over-The-Counter Use (Part 21 CFR 801Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

(Division Sign-Off) (Division of General, Restorations of CDRH, Office of Device Evaluation (ODE) and Neurological Devices

OR

**510(k) Number** K052137