Triathlon CS (Condylar Stabilizing) Lipped Insert
510(k) K063423
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063423 | Date22 Jan 2007 | StatusActive |
Official records
- FDA 510(k) database K063423
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
The Triathlon CS (Condylar Stabilizing) Lipped Insert is a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer designed for total knee arthroplasty. It serves as a modular tibial component, offering anterior constraint to stabilize the knee joint while accommodating surgical decisions regarding the Posterior Cruciate Ligament (PCL). The lipped design enhances mechanical interface stability within the knee prosthesis.
This insert is supplied sterile and intended for single-use only. It is classified under FDA product code JWH and was granted 510(k) clearance (K063423) under the Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) in 2007. Compatible with cemented fixation, it is intended for use in orthopedic settings where PCL retention or sacrifice is a surgical consideration.