Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws
FDA 510(k) clearance K213126 · decided 2022-09-29
Clearance details
- K-number
- K213126
- Device name
- Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-27
- Decision date
- 2022-09-29
- Days to decision
- 367 days
- Clearance type
- Traditional
- Product code
- JDO
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OsteoCentric Integrated Hip Fastener System (K230764) | OsteoCentric Technologies | 2023-04-18 |
| OsteoCentric Integrated Hip Fastener System (K210247) | Osteocentric Technologies D.B.A. Osteocentric Trauma | 2021-04-30 |
| CONQUEST FN (K193029) | Smith & Nephew, Inc. | 2020-02-28 |
| THP Hip Fracture Plating System (K173826) | Biomet, Inc. | 2018-02-07 |
| CONQUEST FN (K172785) | Smith & Nephew | 2017-12-22 |
| CONQUEST FN (K152686) | Smith & Nephew | 2016-03-17 |
| TSP HIP FRACTURE PLATING SYSTEM (K140018) | Biomet, Inc. | 2014-04-04 |
| HIPLOC COMPRESSION HIP SCREW (K080685) | Biomet Manufacturing, Inc. | 2008-08-15 |
| INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (K080434) | Smith & Nephew, Inc. | 2008-04-10 |
| GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM (K983814) | Efratgo, Ltd. HI Tech Bio-Surgical | 1999-01-14 |
| SYNTHES (USA) DHS HELIX SYSTEM (K981757) | Synthes (Usa) | 1998-07-17 |
| SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION (K964259) | Synthes (Usa) | 1997-01-09 |
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 |