This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for changes in the bone cement composition. The device, as modified, will be marketed under the trade name osteopal (e-flow) and is indicated for use as a bone cement in arthroplastic procedures of the hip, knee, and other joins to fix plastic and metal prosthetic parts to living bone when recondstruction is necessary because of osteoarthritis, nonunion of fractures of the neck of the femur, sickle cell anemai, osteoporosis, secondary severe joint destruction following trauma or toehr conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.
| Device | PALACOS E-FLOW (OSTEOPAL) BONE CEMENT |
| Generic Name | Bone Cement |
| Applicant | SMITH & NEPHEW RICHARDS, INC. |
| Date Received | 1995-07-20 |
| Decision Date | 1998-07-30 |
| PMA | P810020 |
| Supplement | S004 |
| Product Code | LOD |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SMITH & NEPHEW RICHARDS, INC. 1450 Brooks Rd. memphis, TN 38116 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810020 | Original Filing | |
| S005 | 1998-09-14 | Real-time Process |
| S004 | 1995-07-20 | Normal 180 Day Track |
| S003 | 1991-11-05 | Normal 180 Day Track |
| S002 | 1988-12-12 | Normal 180 Day Track |
| S001 | 1984-06-04 |