NATURAL-KNEE II REVISION FEMORAL SPACER LUGS

K970498 · Intermedics Orthopedics · JWH · Apr 30, 1997 · Orthopedic

Device Facts

• Record ID: K970498
• Device Name: NATURAL-KNEE II REVISION FEMORAL SPACER LUGS
• Applicant: Intermedics Orthopedics
• Product Code: JWH · Orthopedic
• Decision Date: Apr 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Natural-Knee II Revision Femoral Spacer Lugs are intended for cemented use with the previously cleared Natural-Knee II Revision Femoral Component and associated components (e.g., tibial, patellar, etc.) in the treatment of: 1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. 2. Correctable valgus-varus deformity and moderate flexion contracture. 3. Those patients with failed previous surgery where pain, deformity or dysfunction persists. 4. Revision of previously failed knee arthroplasty.

Device Story

Femoral spacer lug; threaded bolt design; screws into blind holes on inner box of Natural-Knee II Revision Femoral Component; hexagonal head for tightening; secures femoral spacer component; provides medial-lateral stability when used without spacer; used in orthopedic surgery; physician-operated; provides mechanical fixation; benefits patient by restoring joint stability and function in revision arthroplasty.

Clinical Evidence

Bench testing only; analysis of lug shear strength performed to confirm component survival under physiologic loading.

Technological Characteristics

Threaded bolt design; hexagonal head; material not specified; cemented fixation; mechanical stability principle.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis), inflammatory joint disease (e.g., rheumatoid arthritis), correctable valgus-varus deformity, moderate flexion contracture, or failed previous knee arthroplasty requiring revision.

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

• Smith & Nephew Richards Genesis and Tricon-M FlexLok Pegs
• Smith & Nephew Richards Genesis Modular Femoral Lugs
• Howmedica Duracon Modular Femoral Pegs

Submission Summary (Full Text)

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K970498
510(k) SUMMARY
APR 30 1997

January 22, 1997

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Sulzer Orthopedics Inc. Natural-Knee® II Revision Femoral Spacer Lugs.

**Submitter:**
Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, TX 78717
[phone]

**Contact Person:**
Jacquelyn Hughes
Manager, Regulatory Affairs

**Classification Name:**
Knee joint femorotibial metal/polymer semi-constrained cemented prothesis, 21 CFR 888.3530.

**Common/Usual Name:**
Femoral Spacer Lugs

**Trade/Proprietary:**
Natural-Knee® II Revision Femoral Spacer Lugs

**Product Description/Substantial Equivalence:**

The Natural-Knee II Revision Femoral Spacer Lug is in effect a bolt. The threaded portion of the lug screws into blind holes on the inner box of the Natural-Knee II Revision Femoral Component. A large hexagonal head allows the lug to be tightened into place. When used with a femoral spacer, the lug holds the spacer component firmly in place. When used without the spacer, the lug provides medial-lateral stability similar to that of conventionally cast or machined pegs usually found on the inner box of most femoral components.

Analysis of the lug shear strength indicated that the component should survive physiologic loading.

The Natural-Knee II Revision Femoral Spacer Lugs are similar to the Smith & Nephew Richards Genesis and Tricon-M FlexLok Pegs, the Smith & Nephew Richards Genesis Modular Femoral Lugs, and the Howmedica Duracon Modular Femoral Pegs.

The Natural-Knee II Revision Femoral Spacer Lugs are intended for cemented use with the previously cleared Natural-Knee II Revision Femoral Component and associated components (e.g., tibial, patellar, etc.) in the treatment of:

1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
2. Correctable valgus-varus deformity and moderate flexion contracture.
3. Those patients with failed previous surgery where pain, deformity or dysfunction persists.
4. Revision of previously failed knee arthroplasty.

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