EVOLUTION MP ADAPTIVE PS TIBIAL INSERT

• K Number: K131679
• Device Name: EVOLUTION MP ADAPTIVE PS TIBIAL INSERT
• Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC.
• Date Cleared: 2013-10-23 ( 135 days)
• Product Code: JWH , HRY
• Regulation Number: 888.3560
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K093552 , K113325

Intended Use

The EVOLUTION® MP Adaptive PS Insert is indicated for use in knee arthroplasty 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; and treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION® Total Knee System is for cemented use only.

Device Description

The purpose of this submission is to introduce a new EVOLUTION® MP Adaptive PS Tibial Insert that allows use of a posterior stabilized femoral component from the EVOLUTION® MP Total Knee System with a tibial base from the ADVANCE® Knee System.
The design features of the EVOLUTION® Adaptive CS Insert are summarized below:

• Tibial inserts manufactured from UHMWPE
• Available in 7 sizes, left and right
• Tibial insert thickness: 10 20mm

AI/ML Overview

This document does not describe an AI/ML medical device. It pertains to a physical medical device, specifically a tibial insert for knee arthroplasty. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement for an AI/ML device is not applicable and cannot be extracted from this text.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.