Lineage A-Class Poly Liner
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K052026
Overview
The Lineage A-Class Poly Liner is a prosthesis for hip arthroplasty, specifically a semi-constrained acetabular component made from ultra high molecular weight polyethylene (UHMWPE). It features a locking mechanism to secure the liner into the acetabular shell and is available with 0° and 15° overhangs.
It is supplied as a sterile, single-use device intended for use in total hip arthroplasty procedures. The device received FDA 510(k) clearance (K052026) on December 5, 2005, and is classified as Class II with product code LPH under special controls for hip prostheses.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052026 | Date5 Dec 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Wrightmedicaltechnologyinc
Questions
What is the Lineage A-Class Poly Liner used for?
The Lineage A-Class Poly Liner is a prosthesis specifically designed for hip arthroplasty as a semi-constrained acetabular component. It is made from ultra high molecular weight polyethylene and features a locking mechanism to secure it into the acetabular shell.
How is the Lineage A-Class Poly Liner supplied?
The device is supplied as a sterile, single-use item intended for use in total hip arthroplasty procedures. It comes in two configurations with 0° and 15° overhangs to accommodate different surgical needs.
What is the regulatory status of the Lineage A-Class Poly Liner?
The Lineage A-Class Poly Liner received FDA 510(k) clearance (K052026) on December 5, 2005. It is classified as Class II with product code LPH under special controls for hip prostheses.
Can the Lineage A-Class Poly Liner be reused?
No, the Lineage A-Class Poly Liner is designed as a single-use device only. It should not be reused on multiple patients as this could compromise sterility and device performance.