KINEMAX PLUS TIBIAL SPACERS

K964951 · Howmedica Corp. · JWH · Feb 24, 1997 · Orthopedic

Device Facts

• Record ID: K964951
• Device Name: KINEMAX PLUS TIBIAL SPACERS
• Applicant: Howmedica Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 24, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kinemax® Plus Tibial Spacers are intended to be used with the tibial baseplates of the Kinemax® Plus and Kinemax® Plus Superstabilizer total knee systems in primary or revision total knee replacement procedures where there is bone loss on the tibia that requires augmentation for stability. The spacers may be cemented to the baseplate, or may be mechanically locked into place with fixation screws or fixation pegs. The baseplate-spacer assembly is then cemented onto the prepared proximal tibia.

Device Story

Kinemax® Plus Tibial Spacers; orthopedic implants for total knee arthroplasty. Input: bone loss on proximal tibia. Operation: spacers (half, full, full angled) attach to tibial baseplates via cement, fixation screws, or fixation pegs; baseplate-spacer assembly cemented to prepared tibia. Used in OR by orthopedic surgeons. Output: augmented tibial baseplate providing stability. Benefit: restores joint stability in presence of bone defects.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: cast Vitallium® alloy (spacers); wrought or cast Vitallium® alloy (fixation screws/pegs). Form factor: half, full, and full angled spacers. Sterilization: sterile.

Indications for Use

Indicated for patients undergoing primary or revision total knee replacement requiring tibial augmentation due to bone loss for stability.

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® Tibial Wedges - Howmedica (K915512)
• Kinemax® Angled Tibial Wedge - Howmedica (K884837)
• Insall-Burstein II Half and Full Tibial Wedges - Zimmer (K872379)
• Maxim Tibial Augmentation Blocks - Biomet (K915132 and K922285)
• CKS Tibial Spacers - Techmedica (K896542, K901457, K903286, and K914072)

Submission Summary (Full Text)

{0}

K 96 4 951

510(k) Summary

FEB 24 1997

Device: Kinemax® Plus Tibial Spacers

The Kinemax® Plus Tibial Spacers are intended to be used with the tibial baseplates of the Kinemax® Plus and Kinemax® Plus Superstabilizer total knee systems in primary or revision total knee replacement procedures where there is bone loss on the tibia that requires augmentation for stability. The spacers may be cemented to the baseplate, or may be mechanically locked into place with fixation screws or fixation pegs. The baseplate-spacer assembly is then cemented onto the prepared proximal tibia.

There are three types of spacers in the Kinemax® Plus Tibial Spacer System: a half spacer, a full spacer, and a full angled spacer. These spacers are fabricated from cast Vitallium® alloy. The fixation screws and pegs used to secure these spacers to the tibial baseplates are fabricated from wrought or cast Vitallium® alloy. These products will be sold sterile.

The Kinemax® Plus Tibial Spacers are substantially equivalent to other legally marketed products. Examples of these products are listed below:

1. Duracon® Tibial Wedges - Howmedica (K915512)
2. Kinemax® Angled Tibial Wedge - Howmedica (K884837)
3. Insall-Burstein II Half and Full Tibial Wedges - Zimmer (K872379)
4. Maxim Tibial Augmentation Blocks - Biomet (K915132 and K922285)
5. CKS Tibial Spacers - Techmedica (K896542, K901457, K903286, and K914072)

An analysis of equivalent features was presented.

For information contact:

Margaret F. Crowe
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
Telephone: [phone]
Facsimile: [phone]