CONSENSUS PCL SUBSITUTING TIBIAL INSERT

K953443 · U.S. Medical Products, Inc. · JWH · Apr 26, 1996 · Orthopedic

Device Facts

• Record ID: K953443
• Device Name: CONSENSUS PCL SUBSITUTING TIBIAL INSERT
• Applicant: U.S. Medical Products, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Apr 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Consensus® PCL Substituting Tibial Insert is indicated for use in: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. 2. Failed osteotomy or unicompartmental replacements 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

Device Story

Consensus® PCL Substituting Tibial Insert; asymmetric UHMWPE component; articulates with Consensus® Knee primary femoral component; replaces posterior cruciate ligament function; features inferior dovetail grooves for interlocking with tibial baseplate; available in three sizes and five thicknesses; provided sterile; used by orthopedic surgeons in clinical/OR settings; restores joint function; facilitates knee arthroplasty.

Clinical Evidence

No clinical data required; substantial equivalence established via non-clinical performance data.

Technological Characteristics

Material: Ultra-high molecular weight polyethylene (ASTM F648). Design: Asymmetric cruciate-substituting tibial component with inferior dovetail grooves for baseplate interlocking. Dimensions: 3 sizes, 5 thicknesses. Sterilization: Provided sterile.

Indications for Use

Indicated for patients requiring primary knee intervention due to rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis; failed osteotomy or unicompartmental replacements; or revision of unsatisfactory cemented/press-fit knee components with sufficient bone stock.

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

• Intermedics Orthopedics, Inc. Natural Knee® Ultracongruent Tibial Insert (K912663)

Submission Summary (Full Text)

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APR 26 1996
K953443

ATTACHMENT 8 (Amended 10/17/95)

Summary of Safety and Effectiveness

510(k) SUMMARY

US MEDICAL PRODUCTS, INC.
CONSENSUS® PCL SUBSTITUTING TIBIAL INSERT

US Medical Products, Inc.
12201 Technology Boulevard
Suite 100
Austin, Texas 78727

William N. Thompson, Director
Quality Assurance and Regulatory Affairs
Voice [phone]
Fax [phone]
Date of Preparation: 17 Oct 1995

Trade Name: Consensus® PCL Substituting Tibial Insert

Common Name: posterior cruciate ligament substituting tibial insert knee prosthesis

Classification Name: Prosthesis, knee, patello/femorotibial, semi-constrained, cemented, polymer/metal/polymer, under classification 21CFR888.3560.

Substantial Equivalence: equivalent PCL Substituting Tibial Insert component:

Intermedics Orthopedics, Inc. Natural Knee® Ultracongruent Tibial Insert
K912663
SE 09-16-91

Device Description: The Consensus® Knee PCL Substituting Tibial Insert component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is an asymmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for positive interlocking with the tibial baseplate. The design is available in three sizes and each size is available in five thicknesses. The Consensus® PCL Substituting Tibial Insert will be provided sterile.

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K 953443

The Consensus® PCL Substituting Tibial Insert is designed for use with the following Consensus® Total Knee System components:

- Consensus® Nonporous CoCr Femoral component
- Consensus® Porous CoCr Femoral Component
- Consensus® All Poly Patellar component
- Consensus® Metal Back Patellar component
- Consensus® Porous Titanium Stemmed Tibial Baseplate
- Consensus® Nonporous Titanium Stemmed Tibial Baseplate
- Consensus® CoCr Stemmed Tibial Baseplate

Intended Use: The Consensus® PCL Substituting Tibial Insert is indicated for use in:

1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
2. Failed osteotomy or unicompartmental replacements
3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

Summary of Technological Characteristics: The Consensus® PCL Substituting Tibial Insert is an asymmetric UHMWPE cruciate-substituting tibial component designed to articulate with the Consensus® Knee primary femoral component. The inferior surface of each component employs dovetail grooves for positive interlocking with the tibial baseplate. The design is available in three sizes and each size is available in five thicknesses.

Performance Data: The device performs with substantial equivalence to predicate devices.

Clinical Data: None Required

Conclusions from Non-clinical and Clinical Data: The Consensus® PCL Substituting Tibial Insert is substantially equivalent to the predicate device.

Other Necessary Information: None Required