PFC SIGMA LUGGED TIBIAL TRAY

K003026 · DePuy Orthopaedics, Inc. · JWH · Jun 19, 2001 · Orthopedic

Device Facts

• Record ID: K003026
• Device Name: PFC SIGMA LUGGED TIBIAL TRAY
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PFC Sigma Lugged Tibial Tray is intended to provide increased mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives. Caution: This knee prosthesis component is intended for cemented use only.

Device Story

PFC Sigma Lugged Tibial Tray is a knee prosthesis component designed for cemented total knee arthroplasty. Device features four angled pegs for fixation and anti-rotational stability; includes one optional screw hole for additional fixation. Manufactured from titanium alloy (Ti-6Al-4V) with a commercially pure titanium porous coating on the distal surface to facilitate cement fixation. Used in conjunction with P.F.C. Modular and P.F.C. Sigma tibial inserts. Implanted by orthopedic surgeons in clinical settings to replace damaged knee joint articulation, aiming to reduce pain and improve patient mobility.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is supported by device description and conformance to ASTM F-1580 and ASTM F1044 performance standards.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V) with commercially pure titanium porous coating. Design: Tibial tray with four angled pegs and optional screw hole. Standards: ASTM F-1580, ASTM F1044. Fixation: Cemented use only. Compatibility: P.F.C. Modular and P.F.C. Sigma tibial inserts.

Indications for Use

Indicated for patients requiring total knee replacement due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implants. Suitable for elderly patients with severely painful/disabled joints and select younger patients with limited activity demands. Contraindicated in patients lacking sufficient sound bone to support components.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Trick Modular Knee Tibial Tray -Porous (K931054)
• P.F.C. Sigma Porous Modular Keel Tibial Tray (K991106)

Submission Summary (Full Text)

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# JUN 1 9 2001

## 510(k) Summary PFC Sigma Lugged Tibial Tray

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

### A. Contact Person:

Janet G. Johnson, RAC Group Leader, Regulatory Submissions [phone]

### B. Device Information:

| Proprietary Name: | PFC Sigma Lugged Tibial Tray |
|----------------------|----------------------------------------------------------------------------------------------|
| Common Name: | Tibial Tray |
| Classification Name: | Knee Joint Patellofemorotibial polymer/metal/polymer<br>semi-constrained cemented prosthesis |
| Regulatory Class: | Class II, per 21 §CFR 888.3560 |
| Product Code: | 87 JWH |

#### C. Indications for Use:

The PFC Sigma Lugged Tibial Tray is intended to provide increased mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives.

Caution: This knee prosthesis component is intended for cemented use only.

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## 510(k) Summary (Continued) PFC Sigma Lugged Tibial Tray

### D. Device Description:

The PFC Sigma Lugged Tibial Tray is designed with four angled pegs to provide firm fixation and anti-rotational properties while preserving bone stock. It is manufactured from titanium alloy (Ti-6A1-4V) and the distal surface is coated with commercially pure titanium porous coating to enhance cement fixation. If additional fixation is required, the tibial tray is designed with one screw hole to accept a bone screw.

The PFC Sigma Lugged Tibial Tray is designed for use with both P.F.C. Modular and P.F.C. Sigma tibial inserts, including curved, posterior lipped and stabilized.

#### E. Substantial Equivalence:

The PFC Sigma Lugged Tibial Tray is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the Trick Modular Knee Tibial Tray -Porous (K931054) and the P.F.C. Sigma Porous Modular Keel Tibial Tray (K991106).

The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards, e.g. ASTM F-1580, and ASTM F1044.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

JUN 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janet G. Johnson, RAC Group Leader, Regulatory Submissions Depuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K003026

Trade Name: PFC Sigma Lugged Tibial Tray Regulation Number: 888.3560 Regulatory Class: II Product Code: JWH Dated: March 23, 2001 Received: March 26, 2001

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 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). 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 (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 requirements, 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.

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Page 2 - Ms. Janet G. Johnson, RAC

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.

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" (21CFR 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 [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

lelluror

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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510(k) Number (if known) Device Name

KOD 3026 PFC Sigma Lugged Tibial Tray

## Indications for Use

The PFC Sigma Lugged Tibial Tray is intended to provide increased mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives.

Caution: This knee prosthesis component is intended for cemented use only.

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mr. Mr. Mr. Mr. Mr. Mr. Mr. Mr. Mr. Mr.

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

OR

KOO 3026 510(k) Number _

Prescription Use X (Per 21 CFR §801.109)

Over-the-Counter Use

(Optional Format 1-2-96)