Lineage HA Acetabular Shells
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K043099
Overview
The Lineage HA Acetabular Shells are classified as Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) under FDA nomenclature. These devices are metal acetabular shells designed for uncemented total hip arthroplasty, featuring a Hydroxylapatite (HA) coating to enhance osseointegration and stability in the acetabulum.
Intended for single-use in orthopedic surgery, these shells are supplied sterile and require no additional preparation beyond standard surgical protocols. They are regulated under FDA 510(k) clearance (K043099) and fall under device class III. Multiple reference codes (e.g., 3020282716, 1000116912) correspond to distinct shell sizes and configurations, all intended for uncemented fixation in hip replacement procedures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043099 | Date29 Sep 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- Withdrawn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
- KWA
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3330
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
Are the Lineage HA Acetabular Shells designed for cemented or uncemented hip replacement procedures, and what makes them suitable for the chosen method?
The Lineage HA Acetabular Shells are specifically designed for uncemented total hip arthroplasty. Their suitability for uncemented fixation comes from the Hydroxylapatite (HA) coating, which promotes osseointegration—meaning the shell bonds directly to the bone over time, enhancing stability without the need for bone cement.
How many distinct sizes or configurations are available for the Lineage HA Acetabular Shells, and how are they identified?
The Lineage HA Acetabular Shells come in multiple sizes and configurations, each corresponding to a unique FEI number (e.g., 3020282716, 1000116912). These identifiers are used to distinguish shell dimensions and designs, ensuring compatibility with different patient anatomies during uncemented hip replacement procedures.
Do these shells require any special preparation before use in surgery, and how are they supplied?
No special preparation beyond standard surgical protocols is required. The Lineage HA Acetabular Shells are supplied sterile and intended for single-use, meaning they are ready for immediate use in the operating room without additional sterilization or handling.
What regulatory pathway was followed for FDA clearance of these acetabular shells, and what class does this device fall under?
The Lineage HA Acetabular Shells were cleared through the FDA 510(k) pathway under clearance number K043099, following a Traditional review by the Orthopedic (OR) Advisory Committee. They are classified as Class III devices, reflecting their role in a high-risk surgical procedure (total hip arthroplasty).