ASCENSION PYROSPHERE (PCS)

K042690 · Ascension Orthopedics, Inc. · KYI · Nov 13, 2004 · Orthopedic

Device Facts

• Record ID: K042690
• Device Name: ASCENSION PYROSPHERE (PCS)
• Applicant: Ascension Orthopedics, Inc.
• Product Code: KYI · Orthopedic
• Decision Date: Nov 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ascension® PyroSphere® is intended to replace the joint between the first metacarpal and the trapezium 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 PyroSphere is a single-use, spherical, interpositional prosthesis for the basal thumb joint; replaces joint between first metacarpal and trapezium. Device fabricated from thick pyrocarbon layer encasing graphite 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 post-traumatic thumb conditions. Provides mechanical joint replacement to restore function and reduce pain.

Clinical Evidence

No clinical data provided; substantial equivalence based on design features and performance testing.

Technological Characteristics

Spherical interpositional prosthesis; pyrocarbon layer over graphite core; radiopaque via 1% tungsten impregnation. Five sizes available. Single-use; sterile.

Indications for Use

Indicated for patients with rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation/bone loss of the basal thumb joint, presenting with pain, instability, 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

• Ceramic Zirconia Spherical CMC Implant (K960659)
• Ascension PyroHemiSphere (K041451)

Submission Summary (Full Text)

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K042690

Page 28 of 93

| DEC 1 3 2004 | 510(k) SUMMARY |
|------------------|----------------------------------------------------------------------------------|
| SUBMITTER NAME: | Ascension Orthopedics, Inc.<br>8200 Cameron Road, C-140<br>Austin, TX 78754-3832 |
| CONTACT: | Peter Strzepa<br>Phone: [phone]<br>Fax: [phone] |
| DATE OF SUMMARY: | 28 September 2004 |
| TRADE NAME: | Ascension® PyroSphere® |
| COMMON NAME: | carpometacarpal (CMC) implant |
| CLASSIFICATION: | 21 CFR §888.3770 |
| PRODUCT CODE: | 87 KYI |
| PANEL: | Orthopedic and Rehabilitation Devices |

#### PREDICATE DEVICE:

Ceramic Zirconia Spherical CMC Implant (K960659) Ascension PyroHemiSphere (K041451)

### DEVICE DESCRIPTION:

The Ascension PyroSphere (PCS) is a single-use, spherical, interpositional prosthesis for the basal thumb joint. It is fabricated from a thick pyrocarbon layer encasing a graphites core that is impregnated with one-atomic percent tungsten so it is radiopaque. The device is avoilable in five sizes and is provided sterile in packaging containing a single component.

### INTENDED USE:

The Ascension PyroSphere is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as cither 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 PyroSpherc is substantially equivalent to the predicate devices.

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Public Health Service

DEC 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042690

Trade/Device Name: Ascension® PyroSphere® Regulation Numbers: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: September 28, 2004 Received: September 29, 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.

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Page 2 - Mr. Peter Strzepa

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 N. Milleson

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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Ascension® PyroSphere® Device Name:

Indications for Use:

The Ascension® PyroSphere® is intended to replace the joint between the first metacarpal and the trapezium 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milkerson

Restorative, and Neurological Devices

**510(k) Number** K042690