This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the osteonics constrained acetabular insert. This device is indicated for use as a component of a total hip prosthesis in patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint laxity, or intraoperative instability.
| Device | OSTEONICS CONSTRAINED ACETABULAR INSERT |
| Generic Name | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP. |
| Date Received | 1996-12-16 |
| Decision Date | 1997-06-13 |
| Notice Date | 1997-11-17 |
| PMA | P960047 |
| Supplement | S |
| Product Code | KWZ |
| Docket Number | 97M-0459 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOWMEDICA OSTEONICS CORP. 59 Route 17 South allendale, NJ 07401-1677 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 07613327031621 | P960047 | 001 |
| 07613327031478 | P960047 | 001 |
| 07613327031461 | P960047 | 001 |
| 07613327031454 | P960047 | 001 |
| 07613327031447 | P960047 | 001 |
| 07613327031430 | P960047 | 001 |
| 07613327024449 | P960047 | 001 |
| 07613327024364 | P960047 | 001 |
| 07613327024357 | P960047 | 001 |
| 07613327024333 | P960047 | 001 |
| 07613327024326 | P960047 | 001 |
| 07613327024319 | P960047 | 001 |
| 07613327031485 | P960047 | 001 |
| 07613327031492 | P960047 | 001 |
| 07613327031508 | P960047 | 001 |
| 07613327031614 | P960047 | 001 |
| 07613327031607 | P960047 | 001 |
| 07613327031591 | P960047 | 001 |
| 07613327031584 | P960047 | 001 |
| 07613327031577 | P960047 | 001 |
| 07613327031560 | P960047 | 001 |
| 07613327031553 | P960047 | 001 |
| 07613327031546 | P960047 | 001 |
| 07613327031539 | P960047 | 001 |
| 07613327031522 | P960047 | 001 |
| 07613327031515 | P960047 | 001 |
| 07613327024289 | P960047 | 001 |