P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY

K991106 · DePuy Orthopaedics, Inc. · JWH · Jun 9, 1999 · Orthopedic

Device Facts

• Record ID: K991106
• Device Name: P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The P.F.C. Sigma Porous Modular Keel Tibial Tray is indicated for use in total knee replacement in patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention. In accordance with Federal (USA) requirements, the P.F.C. Sigma Knee Modular Keel Tibial Tray is indicated for use only with PMMA bone cement.

Device Story

P.F.C. Sigma Porous Modular Keel Tibial Tray; titanium alloy (Ti-6Al-4V) tibial component for total knee arthroplasty. Distal surface features commercially pure titanium porous coating for cement fixation; includes four screw holes for optional supplemental fixation. Distal tip contains UHMWPE plug, removable to attach metallic extensions for long-stem applications. Designed for use with P.F.C. Modular and P.F.C. Sigma tibial inserts. Used in surgical setting by orthopedic surgeons. Device provides structural replacement of knee joint surfaces; requires PMMA bone cement for fixation. Benefits include pain relief and restoration of joint function for patients with severe structural knee damage.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through conformance with voluntary standards including ASTM F-1580 (porous coatings), ASTM F620 (titanium alloy), and ASTM F1044 (shear testing of porous coatings).

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V) per ASTM F620; porous coating: commercially pure titanium per ASTM F-1580. Features: Modular keel, four screw holes for fixation, removable UHMWPE distal plug for extension attachment. Fixation: Cemented only (PMMA). Sterilization: Not specified.

Indications for Use

Indicated for total knee replacement in patients with severe pain and disability due to permanent structural damage in the knee joint caused by rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma, or failed prior surgical intervention. Must be used with PMMA bone cement.

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

• P.F.C. Modular Tibial Tray -Porous (K892394 and K961685)
• P.F.C. Modular Plus Tibial Tray (K923807 and K961685)
• AMK Total Knee (K864671)
• CRX Tibial Tray (K961379)

Submission Summary (Full Text)

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# K991106

## 510(k) Summary P.F.C. Sigma Porous Modular Keel Tibial Tray

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

### A. Contact Person:

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

#### B. Device Information:

| Proprietary Name: | P.F.C. Sigma Porous Modular Keel Tibial Tray |
|----------------------|-------------------------------------------------------------------------------------------|
| Common Name: | Tibial Tray |
| Classification Name: | Knee Joint Patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class: | Class II, per 21 §CFR 888.3560 |
| Product Code: | 87 JWH |

#### C. Indications for Use:

The P.F.C. Sigma Porous Modular Keel Tibial Tray is indicated for use in total knee The I .. . . Sigma Forde moveing from severe pain and disability due to permanent structural damage in the knew ing from rheumatoid arthritis, osteoarthritis, post-traumatic surthritis, collagen disorders, or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.

In accordance with Federal (USA) requirements, the P.F.C. Sigma Knee Modular Kccl Tibial Tray is indicated for use only with PMMA bone cement.

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#### D. Device Description:

The P.F.C. Sigma Porous Modular Keel Tibial Tray is manufactured from titanium alloy (Ti-6Al-4V). The distal surface, including approximately one-third of the stem and P.F.C. Sigma Porous Modular Keel Tibial Tray portions, is coated with commercially pure titanium porous coating to enhance cement fixation. If additional fixation is required, the tibial tray is designed with four screw holes that accept bone screws.

The distal tip of the P.F.C. Sigma Porous Modular Keel Tibial Tray is manufactured with a UHMWPE plug. When a long stem device is required the UHMWPE plug is removed to allow the tibial tray to accept attachment of a metallic extension.

The P.F.C. Sigma Porous Modular Keel 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 P.F.C. Sigma Porous Modular Keel Tibial Tray is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the P.F.C. Modular Tibial Tray -Porous (K892394 and K961685), P.F.C. Modular Plus Tibial Tray (K923807 and K961685), AMK Total Knee (K864671) and CRX Tibial Tray (K961379).

The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards. e.g. ASTM F-1580, ASTM F620 and ASTM F1044.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

d 1899 JUN

Janet G. Johnson, RAC Janet G. Johnson, Associate Senior Regardic, Inc. P.O. Box 988 700 Orthopaedic Drive 700 Orthopaedio Bossona 46581-0988
Warsaw, Indiana 46581-0988

K991106
P.F.C. Sigma Porous Modular Keel Tibial Tray
Classes Classes Classe, II Re : Regulatory Class : II Product Code: JHW Dated: March 30, 1999 April 1, 1999 Received:

Dear Ms. Johnson:

Deal nove reviewed your Section 510 (k) notification of intent to we have reviewed your Section 510(K) noce have determined the market the for no market the device referenced above and we indications for
device is substantially equivalent (for the indications for device is substantially equivalent (ib) the enables marketed in interestate
use stated in the May 28, 1976 the enactment date of the use stated in the enclosure) to devices manned date of the commerce prior to May 28, 1978, che chaobment Medical Device Amendents of to devices that work.
reclassified in accordance with the provisions of the based of reclassified in accordance with the provisions of the rood, Drug, and Cosmetic Act (Act). Thirs decises labeled
this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone and intended to be fixed within bone were your device subject to cement." You may, therefore, market your act and the following the general control limitations:

- This device may not be labeled or promoted for non-1. cemented use.
- All labeling for this device, including package label
s and for the led within the package, must 2. All labeling for this action the package, must and labeling included within the promises.
prominently state that the device is intended for cemented use only.

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Page 2 Janet G. Johnson, RAC

- 3 . Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class TTT (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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 viter 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 Other general information on your responsibilities under the Act may be

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Page 3 - Janet G. Johnson, RAC

obtained from the Division of Small Manufacturers Assistance obtained from the Division of Small Manufacearch 100 mg 1501 https://www.bac
at its toll-free number [phone] or [phone] obj. at its toll-free number [phone] of (301) 449-697 08-11-2
its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices - Reseord Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known) | |
|--------------------------|--|
| Device Name | |

1991106 P.F.C. Sigma Porous Modular Keel Tibial Tray

## Indications for Use

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nt the r artifits, conagers surgical intervention.

In accordance with Federal (USA) requirements, the P.F.C. Sigma Knee Modular Keel
, In accordance with a more with RMMA bone cement. In accordance with Federal (USA) requirements,
Tibial Tray is indicated for use only with PMMA bone cement.

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Prescription Use_ × (Per 21 CFR §801.109) OR

Over-the-Counter Use_

(Optional Format 1-2-96)

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Division of General Restorative Devices K94104