MODIFICATION TO DEPUY NEUFLEX PIP FINGER

K083107 · DePuy Orthopaedics, Inc. · KYJ · Feb 9, 2009 · Orthopedic

Device Facts

• Record ID: K083107
• Device Name: MODIFICATION TO DEPUY NEUFLEX PIP FINGER
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KYJ · Orthopedic
• Decision Date: Feb 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3230
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modified DePuy NeuFlex PIP Finger Prosthesis is indicated for cementless replacement of the proximal interphalangeal (PIP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

Device Story

Flexible, one-piece silicone implant for proximal interphalangeal (PIP) joint replacement. Features angled proximal and distal stems to mimic relaxed joint position; differs from standard neutral (0°) silicone prostheses. Implanted surgically to restore joint function in patients with arthritis. Benefits include improved anatomical alignment during recovery.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

One-piece silicone elastomer implant. Cementless fixation. Angled stem geometry. Sterilized. No electronic or software components.

Indications for Use

Indicated for patients requiring cementless replacement of proximal interphalangeal (PIP) finger joints disabled by rheumatoid, degenerative, or traumatic 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

• DePuy NeuFlex PIP Finger (K001922)
• NeuFlex MCP Finger Prosthesis (K970544)
• Dow Corning Wright Swanson Finger Implant

Submission Summary (Full Text)

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KOS3107

## 510(k) Summary Modified DePuy NeuFlex PIP Finger Prosthesis

| Applicant / Sponsor: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581 | FEB - 9 2009 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Janet G. Johnson, RAC<br>Manager Regulatory Affairs<br>[phone] | |
| Proprietary Name: | DePuy NeuFlex PIP Finger | |
| Common Name: | Finger Joint Prosthesis | |
| Classification: | 888.3230 Finger joint, polymer, constrained prosthesis | |
| Product Code: | 87 KYJ | |
| Substantial Equivalence | DePuy NeuFlex PIP Finger (K001922)<br>NeuFlex MCP Finger Prosthesis (K970544)<br>Dow Corning Wright Swanson Finger Implant | |

Indications for Use:

The Modified DePuy NeuFlex PIP Finger Prosthesis is indicated for cementless replacement of the proximal interphalangeal (PIP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

Device Description:

The Modified DePuy NeuFlex PIP Finger Prosthesis is a flexible, one-piece silicone implant designed to be implanted across the PIP joint. The proximal and distal stems of the prosthesis form an angle, which mimics the approximate position of the joint when the hand is relaxed. This angle is the most obvious difference between the Modified DePuy NeuFlex PIP Finger Prosthesis and other commercially available silicone finger joint prostheses, which have an unflexed, neutral angle of 0°.

Summary of Technologies/Substantial Equivalence:

The Modified DePuy NeuFlex PIP Finger Prosthesis has the same indications for use, design, materials, sterilization and packaging to the current DePuy NeuFlex PIP Finger (K001922), NeuFlex MCP Finger Prosthesis (K970544) and the Dow Corning Wright Swanson Finger Implant.

The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance performance standards.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an image of an eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics Inc. % Ms. Janet Johnson Manager, Regulatory Affairs P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K083107

Trade/Device Name: DePuv NeuFlex PIP Finger Regulation Number: 21 CFR 888.3230 Regulation Name: Finger joint polymer constrained prosthesis Regulatory Class: II Product Code: KYJ Dated: January 14, 2009 Received: January 15, 2009

Dear Ms. Johnson:

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.

FEB - 9 2009

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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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 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 the reporting 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 N. Milburn

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

510(k) Number (if known)

K 083107

Device Name

DePuy NeuFlex PIP Finger

Indications for Use:

The DePuy NeuFlex PIP Finger Prosthesis is indicated for cementless replacement of the proximal interphalangeal (PIP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use (Per 21 CFR 801 Subpart C)

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milheim

(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of Generalive, Division of General Division of Social Devices

510(k) Number