ADVANCE TIBIAL COMPONENT

K960617 · Wrightmedicaltechnologyinc · HRY · May 8, 1996 · Orthopedic

Device Facts

• Record ID: K960617
• Device Name: ADVANCE TIBIAL COMPONENT
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRY · Orthopedic
• Decision Date: May 8, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ADVANCE™ Tibial Component is intended for tricompartmental or bicompartmental replacement of the knee for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; 5) treatment of fractures that are unmanageable using other techniques.

Device Story

ADVANCE™ Tibial Component; modular two-piece knee replacement system; metal tibial base (cobalt chrome) and plastic insert (UHMWPE). Used in total knee arthroplasty; requires bone cement fixation. Implanted by orthopedic surgeons in hospital setting. Device replaces damaged joint surfaces; restores knee function; reduces pain. Stability provided by femoral-tibial constraint design; locking mechanism secures insert to base. Benefits patient via improved mobility and pain relief.

Clinical Evidence

Bench testing only. Fatigue testing simulated in vivo loading; femoral-tibial contact area testing showed higher conformity than published predicate data; locking detail integrity compared to market systems; femoral-tibial constraint testing (anterior, posterior, medial, lateral shear, and rotation) confirmed stability; UHMWPE material properties verified.

Technological Characteristics

Modular two-piece design; cobalt chrome alloy tibial base; ultra high molecular weight polyethylene (UHMWPE) insert. Cemented fixation. Mechanical stability via femoral-tibial constraint design.

Indications for Use

Indicated for skeletally mature patients requiring tricompartmental or bicompartmental knee replacement due to noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, failed prior treatments/devices, or unmanageable fractures.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Insall/Burstein Modular Total Knee System

Submission Summary (Full Text)

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K960617


# WRIGHT

MEDICAL TECHNOLOGY, INC.

5677 AIRLINE ROAD

ARLINGTON, TN 38002

901-867-9971

Contact Person: Judy English

Date Prepared: February 12, 1996

# 510(k) Summary of Safety and Effectiveness

Trade Name: ADVANCE™ Tibial Component

Common Name: Metal-backed Tibial Component

Product Classification: II

Predicate Device: Insall/Burstein Modular Total Knee System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

# Description/Intended Use

The ADVANCE™ Tibial Component is part of the ADVANCE™ Total Knee System, a total knee replacement system consisting of femoral, tibial, and patellar components. The ADVANCE™ Tibial Component is a modular two-piece component consisting of a metal tibial base and a plastic insert. The ADVANCE™ Tibial Component is intended to be used only with bone cement.

The ADVANCE™ Tibial Component is intended for tricompartmental or bicompartmental replacement of the knee for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; 5) treatment of fractures that are unmanageable using other techniques.

# Materials

The metallic tibial base component is manufactured from cobalt chrome alloy. The tibial insert components are manufactured from ultra high molecular weight polyethylene.

# Testing Summary

- Submitted fatigue testing demonstrates that the ADVANCE™ Tibial Base Component was able to withstand test loading designed to simulate in vivo loading.
- Submitted femoral-tibial contact area testing demonstrates that the ADVANCE™ Tibial Component is more conforming (higher contact area) than independently published data for the predicate device.
- Submitted locking detail testing demonstrates that the ADVANCE™ Tibial Component lock detail integrity is comparable to other posterior stabilized knee systems available on the market.
- Submitted femoral-tibial constraint testing (anterior shear, posterior shear, medial shear, lateral shear, and rotation) demonstrates that the ADVANCE™ Tibial Component is expected to remain stable and resist displacement when subjected to appropriate physiological loads.
- Submitted ultra high molecular weight polyethylene (UHMWPE) properties demonstrate that the ADVANCE™ tibial insert polyethylene components should perform adequately.

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