CORIOGRAPH Knee Pre-Op Plan
FDA 510(k) clearance K240113 · decided 2024-03-18
Clearance details
- K-number
- K240113
- Device name
- CORIOGRAPH Knee Pre-Op Plan
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-01-16
- Decision date
- 2024-03-18
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- PBF
- 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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| Record | Firm | Date |
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| MedCAD® AccuStride™ System (K252064) | Medcad | 2026-03-27 |
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| Newclip Patient-matched instrumentation non sterile PSI (K250767) | Newclip Technics | 2025-10-01 |
| CORIOGRAPH Pre-Op Planning and Modeling Services (K250921) | Blue Belt Technologies, Inc. | 2025-06-25 |
| MedCAD® AccuStride™ System (K241811) | Medcad | 2025-03-13 |
| Newclip Patient-matched instrumentation non sterile PSI (K243912) | Newclip Technics | 2025-02-13 |
| Newclip Patient-matched instrumentation non sterile PSI (K240415) | Newclip Technics | 2024-11-07 |
| Fine Osteotomy™ (K240066) | Bodycad Laboratories, Inc. | 2024-02-09 |
| Newclip Patient-matched instrumentation non sterile PSI (K221615) | Newclip Technics | 2023-10-25 |
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 |