FOUNDATION KNEE SYSTEM TIBIAL COMPONENT

K970031 · Encore Orthopedics, Inc. · JWH · Apr 2, 1997 · Orthopedic

Device Facts

• Record ID: K970031
• Device Name: FOUNDATION KNEE SYSTEM TIBIAL COMPONENT
• Applicant: Encore Orthopedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Apr 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for use of these tibial inserts are noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques. This device is for cemented use only.

Device Story

Tibial component for knee arthroplasty; articulates with Foundation Knee System. Available in six sizes; resurfacing (pegged) and stemmed baseplate designs. Fabricated from wrought Ti-6Al-4V; plasma-sprayed commercially pure titanium underside for cement fixation. Resurfacing component features four smooth pegs, two screw holes, and posterior notch for cruciate ligament retention. Stemmed component features stem for rotational stability and four screw holes. Used by orthopedic surgeons in clinical settings for total knee replacement procedures. Provides mechanical stability and joint surface replacement; facilitates fixation via bone cement; restores joint function in patients with degenerative or traumatic knee conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Wrought Ti-6Al-4V (ASTM F136) baseplates; plasma-sprayed commercially pure titanium coating. Design: Six sizes; resurfacing (pegged) or stemmed configurations. Fixation: Cemented use only. Features: Screw holes for 6.5 mm cancellous screws; posterior notch for cruciate ligament retention.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis), avascular necrosis of femoral condyle, post-traumatic joint loss (with patellofemoral erosion/dysfunction/prior patellectomy), moderate valgus/varus/flexion deformities, rheumatoid arthritis, or fractures unmanageable by other techniques. For cemented use only.

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

• Foundation® Primary Knee System (K923277)
• Biomet Maxim® Knee System

Submission Summary (Full Text)

{0}

03/31/97 MON 15:03 FAX [phone]
K970031

# Summary of Safety and Effectiveness

Encore Orthopedics®, Inc.
9800 Metric Blvd.
Austin, TX 78758
512-834-6237
Ashley M. Bock

APR - 2 1997

**Trade Name:** Tibial Component

**Common Name:** Tibial Component

**Classification Name:** Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis.

**Description:** The resurfacing and pegged tibial components are available in six sizes, articulate with the existing Foundation® Knee System. The baseplates are fabricated from wrought Ti-6Al-4V that conforms to ASTM F136. The under side of both baseplates is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance cement fixation. The resurfacing baseplate has four smooth pegs and two screw holes to allow the use of 6.5 mm cancellous type screws. The resurfacing component has a notch cut out posteriorly to allow retention of the posterior cruciate ligament. The stemmed tibial baseplate has a stem for rotational stability and four screw holes.

**Indications:** The indications for use of these tibial inserts are noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, rheumatoid arthritis, treatment of fractures that are unmanageable using other techniques. This device is for cemented use only.

**Comparable Features to Predicate Device(s):** This device is similar in features, design and indications as the Foundation® Primary Knee System (K923277) and Biomet Maxim® Knee System.