Basic Information
- Trade Name
- OSTEONICS CONSTRAINED ACETABULAR INSERT
- PMA Number
- P960047
- Supplement Number
- S001
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 2, 1998
- Date Received
- February 27, 1998
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- N
Advisory Committee Statement
Approval for: 1) The introduction of 10 additional sizes to the PMA-approved constrained acetabular insert product line; 2) A minor modification in the packaging scheme applicable to the PMA-approved constrained acetabular insert product line; 3) Manufacturing tolerance changes to the PMA-approved constrained acetabular insert product line; and 4) An inspection code modification on the engineering drawing for the PMA-approved constrained acetabular insert product line. The device, as modified, will be marketed under the trade name Osteonics Constrained Acetabular Insert and is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.