VERSABOND BONE CEMENT
FDA 510(k) clearance K001160 · decided 2000-12-11
Clearance details
- K-number
- K001160
- Device name
- VERSABOND BONE CEMENT
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-10
- Decision date
- 2000-12-11
- Days to decision
- 245 days
- Clearance type
- Abbreviated
- Product code
- LOD
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Refobacin Bone Cement R (110034355) (K254107) | Biomet France | 2026-04-15 |
| SPECTRUM GV Bone Cement (K250760) | Osteoremedies, LLC | 2025-04-02 |
| OSTEOPAL® V (K241674) | Heraeus Medical GmbH | 2024-12-05 |
| SPECTRUM® GV Bone Cement (K231556) | Osteoremedies, LLC | 2023-12-20 |
| Bone Cement Genta, Bone Cement HV, Bone Cement LV (K211163) | Tecres S.P.A. | 2023-01-09 |
| Bone Cement-Normal Viscosity (K212729) | Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda | 2022-05-31 |
| OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement (K211869) | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE | 2022-05-19 |
| PALACOS MV pro (K213812) | Heraeus Medical GmbH | 2022-02-02 |
| PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro (K210607) | Heraeus Medical GmbH | 2021-07-09 |
| BonOs Inject, Pedicle screw kits, Cement pusher (K202458) | Osartis GmbH | 2021-05-18 |
| BonOs HV Genta, BonOs MV Genta, BonOs LV Genta (K210125) | Osartis GmbH | 2021-03-19 |
| BonOs HV, BonOs MV, BonOs LV (K210120) | Osartis GmbH | 2021-03-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |