ASCENSION SILICONE PIP

K082231 · Ascension Orthopedics, Inc. · KYJ · Jan 12, 2009 · Orthopedic

Device Facts

• Record ID: K082231
• Device Name: ASCENSION SILICONE PIP
• Applicant: Ascension Orthopedics, Inc.
• Product Code: KYJ · Orthopedic
• Decision Date: Jan 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3230
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for use of the Ascension Silicone PIP are for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.

Device Story

The Ascension Silicone PIP is a single-component, constrained finger joint prosthesis designed for the proximal interphalangeal joint. It features a central flexible hinge with a 15-degree pre-flexed angle and proximal and distal intramedullary stems. The device is implanted by a surgeon to replace damaged joints in patients suffering from advanced arthritis. It functions as a mechanical spacer to restore joint function. The device is provided sterile in six sizes for left or right hand applications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material comparisons to predicate devices.

Technological Characteristics

Single-component silicone polymer spacer; constrained design; central flexible hinge with 15-degree pre-flexed angle; proximal and distal intramedullary stems; six sizes available; sterile.

Indications for Use

Indicated for cementless replacement of the proximal interphalangeal (PIP) joint in patients with advanced osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis.

Regulatory Classification

Identification

A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.

Predicate Devices

• Ascension Silicone MCP (K022892)
• DePuy Neuflex PIP Finger (K001922)

Submission Summary (Full Text)

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K08223i.

| 6 | 510(k) Summary | JAN 12 2009 |
|---|-----------------|---------------------------------------------------------------------------------|
| | SUBMITTER NAME: | Ascension Orthopedics, Inc.<br>8700 Cameron Road, #100<br>Austin, TX 78754-3832 |
| | 510(k) CONTACT: | Debbie Stearns<br>Phone: [phone] x1548 |
| | TRADE NAME: | Ascension® Silicone PIP |
| | COMMON NAME: | Prosthesis, finger, constrained, polymer |
| | CLASSIFICATION: | 21 CFR 888.3230 |
| | PRODUCT CODE: | KYJ |
| | PANEL: | Orthopedic |

# PREDICATE DEVICES:

K022892 - Ascension Silicone MCP K001922 - DePuy Neuflex PIP Finger

## DEVICE DESCRIPTION:

The Ascension® Silicone PIP is a single component silicone spacer consisting of a proximal and distal intramedullary stem and a central flexible hinge. The central flexible hinge has a pre-flexed angle of 15 degrees. The Ascension Silicone PIP is available in 6 sizes for use in left or right applications. Device components are provided sterile in individual packaging.

## INTENDED USE:

The indications for use of the Ascensions Silicone PIP are for replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, posttraumatic arthritis and rheumatoid arthritis.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

A comparison of the Ascension Silicone PIP and the DePuy NeuFlex PIP Finger Implant (K001922) and Ascension Silicone MCP (K022892) show similar material, design features, surgical technique and indications.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper half of the circle. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ascension Orthopedics, Inc. % Ms. Debbie Stearns 8700 Cameron Road, Suite 100 Austin, Texas 78754-3832

JAN 12 2009

Re: K082231

Trade/Device Name: Ascension Silicone PIP Regulation Number: 21 CFR 888.3230 Regulation Name: Finger joint polymer constrained prosthesis Regulatory Class: II Product Code: KYJ Dated: December 23, 2008 Received: December 29, 2008

#### Dear Ms. Stearns:

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

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Page 2 - Ms. Debbie Stearns

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Mulkerson

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 Statement

510(K) Number. K082231

Device Name:

5

Ascension® Silicone PIP

Indications for Use:

The indications for use of the Ascension Silicone PIP are for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.

| Prescription Use | X |
|------------------------------|---|
| (Part 21 CFR 801Subpart B) C | |

OR

| Over-The-Counter Use | |
|-------------------------|--|
| (Part 21 CFR 801Subpart | |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

L 082231