Exactech Posterior Stabilized Cemented Total Knee System
510(k) K933494
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK933494 | Date10 Mar 1995 | StatusActive |
Official records
- FDA 510(k) database K933494
Recalls
-
- Ongoing Z-0019-2022
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
-
- Terminated Z-0522-2007
The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
Timeline
- Cleared FDA 510(k) K933494
- Recall initiated FDA recalls Z-0522-2007
- Recall initiated FDA recalls Z-0019-2022
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- Withdrawn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
- SN
Overview
AI-generated summary, 28 Sep 2026
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 is supplied as a sterile, single-use implant for use in orthopedic surgical procedures. The device received FDA 510(k) clearance (K933494) and is classified as a Class II device under product code JWH with special controls.