Who is the manufacturer of FOUNDATION KNEE SYSTEM?

Encore Orthopedics, Inc. filed the 510(k) submission for FOUNDATION KNEE SYSTEM (K964008).

What is the FDA product code for FOUNDATION KNEE SYSTEM?

JWH. It is classified under 21 CFR 888.3560 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for FOUNDATION KNEE SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for FOUNDATION KNEE SYSTEM?

Foundation® Primary Knee System (K923277); Biomet Maxim® Knee System.

Who can help prepare an FDA 510(k) submission like FOUNDATION KNEE SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FOUNDATION KNEE SYSTEM

K964008 · Encore Orthopedics, Inc. · JWH · Dec 27, 1996 · Orthopedic

Device Facts

Record ID	K964008
Device Name	FOUNDATION KNEE SYSTEM
Applicant	Encore Orthopedics, Inc.
Product Code	JWH · Orthopedic
Decision Date	Dec 27, 1996
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 888.3560
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The indications for use of this femoral insert 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.

Device Story

Femoral component for knee arthroplasty; articulates with Foundation® Knee System. Six sizes available. CoCr alloy (ASTM F75) base; plasma-sprayed commercially pure titanium surface for fixation; two smooth pegs for medial/lateral stability. Used by orthopedic surgeons in clinical/OR settings to replace damaged femoral condyles. Restores joint articulation and stability; addresses degenerative/traumatic joint conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: CoCr alloy (ASTM F75) with plasma-sprayed commercially pure titanium coating. Design: Six sizes; two smooth pegs for stability. Semiconstrained cemented prosthesis.

Indications for Use

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

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

Related Devices

K063515 — TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE · Biomet Manufacturing, Inc. · Feb 2, 2007
K970031 — FOUNDATION KNEE SYSTEM TIBIAL COMPONENT · Encore Orthopedics, Inc. · Apr 2, 1997
K140073 — U2 FEMORAL COMPONENT, CR, CEMENTED · United Orthopedic Corp. · Jun 16, 2014
K073529 — DEPUY SIGMA PS FEMORAL COMPONENTS · DePuy Orthopaedics, Inc. · Jan 24, 2008
K063731 — ADVANCE STATURE FEMORAL COMPONENT · Wrightmedicaltechnologyinc · Mar 2, 2007

Submission Summary (Full Text)

{0} # Summary of Safety and Effectiveness Encore Orthopedics®, Inc. 8900 Shoal Creek BLVD. Suite 300 Austin, TX 78757 512-206-1437 Ashley M. Bock *K924008* DEC 27 1996 **Trade Name:** Femoral Component **Common Name:** Femoral Component **Classification Name:** Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis. **Description:** This femoral component is available in six sizes, to fit into, and articulate with, the existing Foundation® Knee System. The CoCr alloy (ASTM F75) component is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance fixation. The femoral component has two smooth pegs to provide medial/lateral stability. **Indications:** The indications for use of this femoral insert 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. **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.