ASCENSION PYROSPHERE CMC/TMT

{0}------------------------------------------------ # 510(k) SUMMARY | SUBMITTER NAME: | Ascension Orthopedics, Inc.<br>87200 Cameron Road, C-100<br>Austin, TX 78754-3832 | |------------------|-----------------------------------------------------------------------------------| | CONTACT: | Glen Neally<br>Phone: (512) 836-5001 ext 1513<br>Fax: (512) 836-6933 | | DATE OF SUMMARY: | 28 February 2006 | | TRADE NAME: | Ascension® PyroSphere® | | COMMON NAME: | pyrocarbon spherical implant | | CLASSIFICATION: | 21 CFR §888.3730 | | PRODUCT CODE: | KWD | | PANEL: | Orthopedic | K060560 MAY - 5 2005 ### PREDICATE DEVICES: Orthosphere Ceramic Spherical Implant (K030319) Ascension® PyroSphere® (K042690) #### DEVICE DESCRIPTION: The Ascension Ascension® PyroSphere™ CMC/TMT is a single-use, spherical, interpositional prosthesis intended for use in the carpometacarpal (CMC) basal thumb joint or the the 4" /5th tarsometatarsal (TMT) joint involvement. It articulates against recesses prepared in the base of the first metacarpal and the trapezium or the tarsometatarsal joint. #### INTENDED USE: The Ascension® PyroSphere™ CMC/TMT) 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. The Ascension® PyroSphere™ CMC/TMT is also intended for use in the 4th /5th tarsometatarsal (TMT) joint involvement where degenerative or post-traumatic arthritis presents: - . decreased motion - . arthritic changes and/or subluxation - . unstable, stiff, or painful joints - degenerative joint disease of the midfoot associated with gout or pseudogout . ## BASIS OF SUBSTANTIAL EQUIVALENCE: A comparison of the design features as well as performance tests demonstrate that the Ascension® PyroSphere™ CMC/TMT is substantially equivalent to the predicate device. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY -5 2006 Ascension Orthopedics, Inc. Mr. Glen Neally Vice President of QA/RA/CA 8700 Cameron Road, Suite C-100 Austin, Texas 78754-3832 Re: K060560 Trade/Device Name: Ascension® PyroSphere™ CMC/TMT Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: February 28, 2006 Received: March 2, 2006 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 {2}------------------------------------------------ #### Page 2 - Mr. Glen Neally 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. 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/industry/support/index.html . Sincerely yours. Herbert Leonard co for Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health ... ... Enclosure {3}------------------------------------------------ ## Indications For Use 510(K) Number: K060560 Ascension® PyroSphere™ CMC/TMT Device Name: Indications for Use: The Ascension® PyroSphere™ CMC/TMT 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. The Ascension® PyroSphere™ CMC/TMT is also intended for use in the 4th /5th tarsometatarsal (TMT) joint involvement where degenerative or post-traumatic arthritis - presents: - . decreased motion - . arthritic changes and/or subluxation - unstable, stiff, or painful joints . - degenerative joint disease of the midfoot associated with gout or pseudogout . Prescription Use .X (Per 21 CFR 801.109) OR Over-The-Counter Use _ (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) Herbert Lerner Division of General, Restorative and Neurological Devices **510(k) Number** K060560