ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50

K041451 · Ascension Orthopedics, Inc. · KYI · Aug 25, 2004 · Orthopedic

Device Facts

• Record ID: K041451
• Device Name: ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
• Applicant: Ascension Orthopedics, Inc.
• Product Code: KYI · Orthopedic
• Decision Date: Aug 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

Device Story

Ascension PyroHemiSphere is a single-use, uncemented, one-component prosthesis for the basal thumb joint; replaces proximal end of first metacarpal. Device fabricated from thick pyrocarbon layer encasing graphite core; core impregnated with one-atomic percent tungsten for radiopacity. Available in five sizes; provided sterile. Used by orthopedic surgeons in clinical settings to treat arthritis or bone loss. Provides structural replacement to restore joint function, reduce pain, and improve range of motion in the thumb.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design features and performance testing.

Technological Characteristics

Prosthesis composed of a pyrocarbon layer over a graphite core; core impregnated with 1% tungsten for radiopacity. Uncemented, single-component design. Available in five sizes. Provided sterile.

Indications for Use

Indicated for patients requiring replacement of the proximal first metacarpal due to rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation/bone loss, presenting with painful, unstable thumbs or limited range of motion.

Regulatory Classification

Identification

A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.

Predicate Devices

• Swanson Titanium Basal Thumb (K864488)
• Ceramic Zirconia Spherical CMC Implant (K960659)
• Biopro Cobalt Trapeziometacarpal Replacement (K964472)

Submission Summary (Full Text)

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

| AUG 2 5 2004 | 510(k) SUMMARY | page 1 |
|------------------|----------------------------------------------------------------------------------|--------|
| SUBMITTER NAME: | Ascension Orthopedics, Inc.<br>8200 Cameron Road, C-140<br>Austin, TX 78754-3832 | K04145 |
| CONTACT: | Peter Strzepa<br>Phone: [phone]<br>Fax: [phone] | |
| DATE OF SUMMARY: | 28 May 2004 | |
| TRADE NAME: | Ascension® PyroHemiSphereTM | |
| COMMON NAME: | carpometacarpal (CMC) implant | |
| CLASSIFICATION: | 21 CFR §888.3770 | |
| PRODUCT CODE: | 87 KYI | |
| PANEL: | Orthopedic and Rehabilitation Devices | |

### PREDICATE DEVICE:

Swanson Titanium Basal Thumb (K864488) Ceramic Zirconia Spherical CMC Implant (K960659) Biopro Cobalt Trapeziometacarpal Replacement (K964472)

### DEVICE DESCRIPTION:

The Ascension PyroHemiSphere (PHS) is single-use, uncemented, onc-component prosthesis for the basal thumb joint. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The device is available in five sizes and is provided sterile in packaging containing a single component.

# INTENDED USE:

The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first mctacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

A comparison of the design features as well as performance tests demonstrate that the Ascension PyroHemiSphere is substantially equivalent to the predicate device.

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

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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2004

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

Re: K041451

Trade/Device Name: Ascension PyroHemiSphere Regulation Numbers: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: May 28, 2004 Received: June 1, 2004

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 (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. 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.

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

Page 2 -- Mr. Peter Strzepa

Page 2 - Mr. Peter Strzepa

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,

L. Mark A. Milkins

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

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

# Indications For Use

Kodines I 510(K) Number:

Ascension® PyroHemiSphere Device Name:

Indications for Use:

The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

> Prescription Use (Part 21 CFR 801 Subpart D

AND/OR

Over-The-Counter Use (21 CFR 807 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. Milkers

I. Restorative, Division of Ge and Neurological Devices

510(k) I