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.
| Device | OSTEONICS CONSTRAINED ACETABULAR INSERT |
| Applicant | HOWMEDICA OSTEONICS CORP. |
| Date Received | 1998-02-27 |
| Decision Date | 1998-04-02 |
| PMA | P960047 |
| Supplement | S001 |
| Docket Number | N |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOWMEDICA OSTEONICS CORP. 59 Route 17 South allendale, NJ 07401-1677 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P960047 | | Original Filing |
| S003 |
2001-06-22 |
Real-time Process |
| S002 |
2000-03-24 |
Real-time Process |
| S001 |
1998-02-27 |
Real-time Process |
NIH GUDID Devices