System 12 Constrained Acetabular Liners
510(k) K063550
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063550 | Date8 Mar 2007 | 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- Withdrawn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
- KWZ
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3310
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The System 12 Constrained Acetabular Liners are classified as constrained acetabular components for total hip arthroplasty. These devices are designed to replace the acetabulum and femoral head bearing surface, providing stability for patients with degenerative joint disease, trauma, or failed prior prostheses. Their constrained design reduces dislocation risk by mechanically locking the femoral head within the acetabular component. Manufactured for use within the System 12 Hip System, they are intended to restore hip function and mobility in appropriate clinical scenarios.
These liners are supplied as part of a modular hip arthroplasty system and are intended for surgical use by orthopedic specialists. They are not single-use and are intended for reusable applications in sterile operating environments. The device is regulated under FDA 510(k) clearance (K063550) and falls under the Orthopedic Devices advisory committee category. No specific MRI safety classification or sterility assurance level is stated in the regulatory submission. Sizes and configurations are determined by compatibility with the System 12 Hip System components.
Other devices from Howmedica Osteonics Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the System 12 Constrained Acetabular Liners used for?
The System 12 Constrained Acetabular Liners are designed for total hip arthroplasty to replace the acetabulum and femoral head bearing surface. Their constrained design provides mechanical stability, reducing the risk of dislocation in patients with degenerative joint disease, trauma, or failed prior hip prostheses. This makes them ideal for clinical scenarios where stability is critical to restoring hip function and mobility.
Are the System 12 Constrained Acetabular Liners single-use or reusable?
These liners are intended for reusable applications in sterile operating environments. They are part of a modular hip arthroplasty system and must be handled according to standard surgical reprocessing protocols to ensure safety and sterility for subsequent uses.
How do the sizes and configurations of these liners work?
The sizes and configurations of the System 12 Constrained Acetabular Liners are determined by compatibility with the System 12 Hip System components. This modular design ensures proper fit and function within the broader hip replacement system, allowing orthopedic surgeons to select the appropriate liner based on patient anatomy and clinical needs.
What regulatory pathway does the System 12 Constrained Acetabular Liners follow?
The device is regulated under the FDA 510(k) clearance pathway, specifically under clearance number K063550. It was determined to be substantially equivalent to a legally marketed predicate device and falls under the Orthopedic Devices advisory committee category. This classification ensures compliance with FDA standards for orthopedic implants.
Are there any specific storage requirements for these liners?
While the regulatory submission does not specify a sterility assurance level or detailed storage instructions, these liners are intended for surgical use in sterile environments. They should be stored according to standard orthopedic implant protocols to maintain integrity and sterility until use, following manufacturer guidelines for handling and packaging.