ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40

K061451 · Ascension Orthopedics, Inc. · KYI · Aug 11, 2006 · Orthopedic

Device Facts

• Record ID: K061451
• Device Name: ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
• Applicant: Ascension Orthopedics, Inc.
• Product Code: KYI · Orthopedic
• Decision Date: Aug 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ascension® CMC 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. This is an uncemented prosthesis designed for press fit use only.

Device Story

Ascension® CMC is a hemi-joint replacement prosthesis for the base of the first metacarpal (CMC joint). Device features a saddle-shaped articular surface designed to interface with the trapezium, facilitating flexion-extension and abduction-adduction motion. It is an uncemented, press-fit implant. The device consists of a machined graphite substrate impregnated with 1 atomic percent tungsten for radiopacity, encased in a pyrocarbon layer. Used by orthopedic surgeons in clinical settings to address joint pain, instability, or restricted motion resulting from arthritis or trauma. The prosthesis restores joint function by replacing the proximal metacarpal surface.

Clinical Evidence

No clinical data provided. Evidence consists of bench performance testing, in vitro material biocompatibility testing, and pre-clinical animal testing.

Technological Characteristics

Hemi-joint prosthesis; saddle-shaped articular surface. Materials: Machined graphite substrate impregnated with 1 atomic percent tungsten (for radiopacity), encased in a pyrocarbon layer. Uncemented, press-fit design. Sterile, single-use.

Indications for Use

Indicated for patients with rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation/bone loss of the first metacarpal base presenting with painful, unstable thumb 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

• Ascension® PHS (K041451)

Submission Summary (Full Text)

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510(k) Premarket Notification Device: Ascension® CMC

061451

# 510(k) SUMMARY

AUG 1 1 2006 SUBMITTER NAME: Ascension Orthopedics, Inc. 8700 Cameron Road. C-100 Austin, TX 78754-3832 510(k) CONTACT: Glen Neally Ph: [phone] TRADE NAME: Ascension® CMC COMMON NAME: prosthesis, wrist, carpal trapezium CLASSIFICATION: 21 CFR §888.3770 Wrist joint carpal trapezium polymer prosthesis PRODUCT CODE: KYI PANEL: Orthopedic Devices PREDICATE DEVICE: Ascension® PHS, (K041451)

#### DEVICE DESCRIPTION:

The Ascension® CMC is intended for use as a hemi joint replacement for the base of the first metacarpal of the carpometacarpal (CMC) joint. The Ascension CMC is a one component prosthesis having a saddle configuration articular surface which bears against the mating saddle articular surface of the trapczium. The saddle design allows for flexion-extension joint motion and abduction-adduction motion. It is designed to be a press fit device. Each device is comprised of a pyrocarbon layer encasing a machined graphite substrate. The graphite substrate material is impregnated with a small amount (I atomic percent) of tungsten. This small amount of tungsten renders the graphite substrate radiopaque. The device is provided sterile in packaging containing a single device.

#### INTENDED USE:

The Ascension® CMC is intended to replace the proximal end of the first metacarpal in cases of theumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture defonomianon or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

Performance tests conducted on Ascension CMC devices, in vitro material biocompatibility tests, and pre-clinical animal tests demonstrate that the Ascension CMC is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 1 2006

Ascension Orthopedics, Inc. % Mr. Glen Neally VP of QA/RA/CA 8700 Cameron Road, Suite 100 Austin, Texas 78754

Re: K061451

Trade/Device Name: Ascension® CMC Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: Class II Product Code: KYI Dated: May 22, 2006 Received: May 25, 2006

Dear Mr. Neally:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became ine device is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encreate) ve togging to the Medical Device Amendments, or to conninesee prof to may 20, 1978, in excordance with the provisions of the Federal Food, Drug, devices that have been receised in avere approval of a premarket approval application (PMA). and Cosmette Act (1101) that as nevice, subject to the general controls provisions of the Act. The Tourmaly, therefore, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 rr your device to such additional controls. Existing major regulations affecting your device can may oc subject to back additions, 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 I Toast of advised that I Drivedantly that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must of any I oderal buttores and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Far 6075, abounding (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 production of to begin marketing your device as described in your Section 510(k)

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Page 2 - Mr. Glen Neally

premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice 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,

Barbara Buehrig

Mark N. Melkerson 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

06145

510(K) Number:

Ascension® CMC Device Name:

The Ascension® CMC is intended to replace the proximal end of the first Indications for Use: 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. This is an uncemented prosthesis designed for press fit use only.

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)

Aulian Dvelum for mym

1. Restorative, and Neurological Devices

**510(k) Number** K061451