Osteonics Constrained Acetabular Insert
PMA P960047
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP960047 | Date13 Jun 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic name
- Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
- PMA number
- FDA product code
- KWZ
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3310
- Advisory committee
- Orthopedic
- FDA decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The Osteonics Constrained Acetabular Insert is a Prosthesis, hip, constrained, cemented or uncemented, metal/polymer, designed to reduce dislocation risk in total hip arthroplasty. It functions as a component of a total hip prosthesis, providing enhanced stability through mechanical constraint for patients with high dislocation risk factors such as prior dislocations, bone loss, or intraoperative instability.
This device is supplied as a single-use implant, intended for use in orthopedic surgical settings. It may be cemented or uncemented depending on clinical indication, and its design adheres to FDA Pre-Market Approval (PMA P960047). No specific sterility or MRI safety information is provided in the data, but its use is governed by the original PMA authorization for high-risk hip dislocation cases.