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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Ascension® PyroSphere® CMC implant, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) summary focuses on establishing substantial equivalence to predicate devices based on design features and performance tests. It outlines the device description, intended use, and substantial equivalence to previously approved devices (Ceramic Zirconia Spherical CMC Implant (K960659) and Ascension PyroHemiSphere (K041451)).

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and a study to prove its performance against those criteria, as this information is not present in the provided document.

Summary

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K042690

Page 28 of 93

DEC 1 3 2004	510(k) SUMMARY
SUBMITTER NAME:	Ascension Orthopedics, Inc.8200 Cameron Road, C-140Austin, TX 78754-3832
CONTACT:	Peter StrzepaPhone: (512) 836-5001Fax: (512) 836-6933
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:

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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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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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Indications For Use

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Ascension® PyroSphere® Device Name:

Indications for Use:

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

Regulation Number and Section

§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.

(a)
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.(b)
Classification. Class II.