- Device
- OSTEONICS CONSTRAINED ACETABULAR INSERT
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P960047
- Supplement
- S001
- Decision date
- 1998-04-02
- Decision code
- APPR
- Date received
- 1998-02-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.