Triton Hip System
510(k) K003649
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003649 | Date23 Feb 2001 | 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- Withdrawn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
- LWJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3360
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Triton Hip System is a Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented as classified under FDA regulation 888.3360. This orthopedic implant is designed to replace damaged or diseased hip joints, providing structural support and restoring mobility through a semi-constrained articulation between metal and polymer components. The system is intended for uncemented fixation, eliminating the need for bone cement during implantation.
The device is supplied as a sterile, single-use orthopedic implant and is regulated under FDA 510(k) clearance (K003649) with a Traditional review process. It falls under Device Class II and is intended for use in surgical settings by qualified orthopedic surgeons. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to implantation. No additional regulatory status beyond the stated 510(k) clearance is implied.