PALACOS E-FLOW (OSTEOPAL) BONE CEMENT
FDA premarket approval P810020/S004 · decided 1998-07-30
Approval details
- PMA number
- P810020
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 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
- Days to decision
- 1106 days
- Decision code
- APPR
- Product code
- LOD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- 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 c
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EMPOWER ANTERIOR DIRECT SCREWS (K965224) | Smith & Nephew Richards, Inc. | 1997-05-08 |
| GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON (K963509) | Smith & Nephew Richards, Inc. | 1997-01-27 |
| FINN ROD TO ROD CONNECTOR (K960444) | Smith & Nephew Richards, Inc. | 1997-01-24 |
| TRIMAX NAIL SYSTEM (K964163) | Smith & Nephew Richards, Inc. | 1996-12-27 |
| GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT (K962557) | Smith & Nephew Richards, Inc. | 1996-12-05 |
| REVISION HIP SYSTEM (K963486) | Smith & Nephew Richards, Inc. | 1996-11-27 |
| REFLECTION ACETABULAR REINFORCEMENT RINGS (K962541) | Smith & Nephew Richards, Inc. | 1996-09-17 |
| ILIZAROV EXTERNAL FIXATION SYSTEM (K962808) | Smith & Nephew Richards, Inc. | 1996-08-19 |