Tritanium Non-Modular Shell & X3 All-Poly Insert
510(k) K090897
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090897 | Date23 Oct 2009 | 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- Withdrawn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
- LPH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Tritanium Non-Modular Shell & X3 All-Poly Insert is a semi-constrained acetabular hip prosthesis classified as Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous Uncemented (product code LPH). This device consists of a non-modular shell designed for cementless fixation into the prepared acetabulum and an all-polyethylene insert secured within the shell using bone cement.
Intended for use in total hip arthroplasty, this system is paired with compatible femoral stems and heads for primary or revision procedures. Supplied sterile and single-use, the device adheres to FDA 510(k) clearance (K090897) under traditional review. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to surgical application.