DURACON POSTERIOR FEMORAL SPACER

K963242 · Howmedica Corp. · JWH · Nov 14, 1996 · Orthopedic

Device Facts

• Record ID: K963242
• Device Name: DURACON POSTERIOR FEMORAL SPACER
• Applicant: Howmedica Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Duracon® Femoral Posterior Spacer is intended to be used with the femoral components of the Duracon® Total Knee System (reference premarket notifications K910235, K920034, K932070, and K954138) to augment bone loss in the area of the posterior condyle of the femur. Posterior bone loss that requires augmentation by spacers may be noted in primary or revision total knee arthroplasty cases.

Device Story

Orthopedic implant component; used to augment posterior femoral condyle bone loss in total knee arthroplasty. Device cemented to femoral component of Duracon Total Knee System; assembly then cemented into femur. Used in clinical setting by orthopedic surgeons. Provides structural support to address bone defects; facilitates proper joint alignment and stability.

Clinical Evidence

Bench testing only.

Technological Characteristics

Femoral spacer component; metallic construction; designed for cement fixation to femoral implant. Dimensions and form factor specific to Duracon Total Knee System geometry.

Indications for Use

Indicated for patients undergoing primary or revision total knee arthroplasty requiring augmentation of posterior femoral condyle bone loss.

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

• Duracon® Total Knee System Distal Femoral Spacers (K915512)
• Duracon® Total Knee System Distal-Posterior Femoral Spacers (K915512)
• Kinemax® Plus Superstabilizer Total Knee System Femoral Posterior Spacers (K904208)
• Series 7000 Total Knee System Femoral Posterior Spacers
• Genesis Total Knee System Femoral Posterior Spacers
• Coordinate Total Knee System Femoral Posterior Spacers

Reference Devices

• Duracon® Total Knee System (K910235)
• Duracon® Total Knee System (K920034)
• Duracon® Total Knee System (K932070)
• Duracon® Total Knee System (K954138)

Submission Summary (Full Text)

{0}

K963242

510(k) Summary

NOV 14 1996

Device: Duracon® Femoral Posterior Spacer

The Duracon® Femoral Posterior Spacer is intended to be used with the femoral components of the Duracon® Total Knee System (reference premarket notifications K910235, K920034, K932070, and K954138) to augment bone loss in the area of the posterior condyle of the femur. Posterior bone loss that requires augmentation by spacers may be noted in primary or revision total knee arthroplasty cases.

The Duracon® Femoral Posterior Spacer is cemented to the femoral component, and then the spacer-femoral component assembly is cemented into place.

The Duracon® Femoral Posterior Spacer is substantially equivalent to several other legally marketed devices. Examples of these are listed below:

1. Duracon® Total Knee System Distal Femoral Spacers (K915512) - Howmedica
2. Duracon® Total Knee System Distal-Posterior Femoral Spacers (K915512) - Howmedica
3. Kinemax® Plus Superstabilizer Total Knee System Femoral Posterior Spacers (K904208) - Howmedica
4. Series 7000 Total Knee System Femoral Posterior Spacers - Osteonics Corporation
5. Genesis Total Knee System Femoral Posterior Spacers - Smith & Nephew Richards
6. Coordinate Total Knee System Femoral Posterior Spacers - DePuy

For information contact: Margaret F. Crowe
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
[phone]
Fax: [phone]