Plus Total Knee System, Poly Tibial Peg
510(k) K875201
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK875201 | Date17 Feb 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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, 1 Oct 2026
The Plus Total Knee System, Poly Tibial Peg is a patellofemorotibial semi-constrained cemented prosthesis (Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer). This device is designed to replace a damaged knee joint, providing controlled articulation to limit translation and rotation in one or more planes through its polymer/metal/polymer construction. The tibial peg component is intended for secure fixation within bone via cemented implantation. Its semi-constrained design offers stability while accommodating natural knee motion.
This device is supplied as a cemented implant system, requiring surgical implantation by an orthopedic specialist in an operating room setting. It is intended for single-use and must be handled under sterile conditions prior to use. The system includes a polyethylene tibial component with a titanium peg for bony fixation. Storage and handling comply with standard orthopedic implant protocols, and its regulatory clearance (FDA 510K) reflects substantial equivalence for specific indications in orthopedic knee replacement procedures.