Advance Ultra-Congruent Tibial Insert
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K972770
Overview
The Advance Ultra-Congruent Tibial Insert is a semi-constrained, cemented knee prosthesis designed for total knee replacement. Classified as a Prosthesis, Knee, Patellofemorotibial (product code JWH), it is manufactured from ultra-high molecular weight polyethylene (UHMWPE) and intended to replace damaged tibial surfaces within the knee joint. This insert provides enhanced congruency to improve joint stability and functional restoration during arthroplasty procedures.
This device is supplied as a single-use component and requires cement fixation during implantation. It is intended for use in orthopedic settings under sterile conditions, adhering to standard surgical protocols for knee arthroplasty. The Advance Ultra-Congruent Tibial Insert holds an FDA 510(k) clearance (K972770) under the Traditional review pathway, classified as Class II with Special Controls. Compliance with regulatory guidelines ensures safe integration into total knee replacement systems.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972770 | Date21 Oct 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1636-2010
- Terminated Z-1637-2010
The left medial pivot and right medial pivot inserts were co-mingled
Specification
- 510(k) Number
- FDA Product Code
- JWH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What is the Advance Ultra-Congruent Tibial Insert used for?
The Advance Ultra-Congruent Tibial Insert is designed to replace damaged tibial surfaces within the knee joint during total knee replacement (arthroplasty). Its semi-constrained, cemented design enhances joint stability and functional restoration, making it ideal for patients requiring improved congruency and alignment in their knee prosthesis.
How is the Advance Ultra-Congruent Tibial Insert supplied and implanted?
This tibial insert is supplied as a single-use component and requires fixation using bone cement during surgical implantation. It is intended for use in orthopedic settings under sterile conditions, following standard knee arthroplasty protocols to ensure proper integration and function.
What material is the tibial insert made from, and why is it significant?
The insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE), a durable and biocompatible material known for its wear resistance and longevity in joint replacements. This material choice helps reduce friction and wear in the knee joint, contributing to long-term stability and performance.
Is the Advance Ultra-Congruent Tibial Insert reusable or single-use?
The tibial insert is explicitly designed for single-use only. This ensures sterility and reduces the risk of cross-contamination or degradation from repeated sterilization processes, aligning with best practices for orthopedic implants.
What regulatory clearance does the Advance Ultra-Congruent Tibial Insert hold?
The device holds FDA 510(k) clearance (K972770) under the Traditional review pathway, classified as Class II with Special Controls. This clearance confirms its compliance with regulatory standards for knee prostheses, ensuring safe use in clinical settings.