DEPUY NEUFLEX PIP FINGER

K001922 · Depuy, Inc. · KYJ · Aug 29, 2000 · Orthopedic

Device Facts

• Record ID: K001922
• Device Name: DEPUY NEUFLEX PIP FINGER
• Applicant: Depuy, Inc.
• Product Code: KYJ · Orthopedic
• Decision Date: Aug 29, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3230
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

DePuy NeuFlex PIP Finger Prosthesis is a flexible, one-piece silicone implant for proximal interphalangeal (PIP) joint replacement. Device features proximal and distal stems set at an angle to mimic the relaxed hand position, distinguishing it from neutral-angle (0°) silicone prostheses. Implanted by surgeons in clinical settings to restore joint function in patients with arthritis. Provides structural replacement for damaged joints; benefits include improved joint mobility and pain relief.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device description and conformance with voluntary performance standards.

Technological Characteristics

One-piece silicone implant; flexible design; proximal and distal stems angled to mimic relaxed hand position; cementless fixation; sterilized.

Indications for Use

Indicated for patients requiring cementless replacement of the proximal interphalangeal (PIP) joints of the finger due to disability from 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 MCP Finger Prosthesis (K970544)
• Dow Corning Wright Swanson Fingent Involant

Submission Summary (Full Text)

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## AUG 2 9 2000

K 001922

# 510(k) Summary DePuy NeuFlex PIP Finger Prosthesis

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

#### A. Contact Person:

Janet G. Johnson, RAC Senior Regulatory Associate [phone]

#### B. Device Information:

| Proprietary Name: | DePuy NeuFlex PIP Finger |
|-------------------|--------------------------------------------------------|
| Common Name: | Finger Joint Prosthesis |
| Classification: | 888.3230 Finger joint, polymer, constrained prosthesis |
| Product Code: | 87 KYJ |

### C. 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.

#### D. Device Description:

The 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 DePuy NeuFlex PIP Finger Prosthesis and other commercially available silicone finger joint prostheses, which have an unflexed, neutral angle of 0°.

#### E. Substantial Equivalence:

The substantial equivalence of the DePuy NeuFlex PIP Finger Prosthesis is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the current DePuy NeuFlex MCP Finger Prosthesis (K970544) and the Dow Corning Wright Swanson Fingent Involant.

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

3

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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 abstract symbol that resembles three human profiles facing to the right.

### AUG 2 9 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janet G. Johnson, RAC Senior Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K001922

Trade Name: DePuy NeuFlex PIP Finger Regulatory Class: II Product Code: KYJ Dated: June 21, 2000 Received: June 23, 2000

Dear Ms.Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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#### Page 2 - Ms. Janet G. Johnson, RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Stipt Rluzle

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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#### 510(k) Number (if known) KOO1922 " DePuy NeuFlex PIP Finger Device Name

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.

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

| Prescription Use ✓<br>(Per 21 CFR §801.109) | OR | Over-the-Counter Use ______ |
|---------------------------------------------|---------|-----------------------------|
| | | (Optional Format 1-2-96) |
| | | |
| (Division: | | |
| Division | | |
| 510(k) Number | K001922 | |