DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
FDA 510(k) clearance K132636 · decided 2013-10-17
Clearance details
- K-number
- K132636
- Device name
- DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-22
- Decision date
- 2013-10-17
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Smith & Nephew
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RadioViewAI (K260936) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 |
| Cleerly LABS (K260588) | Cleerly, Inc. | 2026-07-29 |
| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
| ImageGrid StreamVue (K262143) | Candelis, Inc. | 2026-07-23 |
| ResolutionMD (K260500) | ResolutionMD, Inc. | 2026-07-21 |
| Avara Viewer (K262120) | Avara Software | 2026-07-10 |
| 3D-Anywhere (K253899) | Provect.AI | 2026-07-09 |
| INDIRA CLOUD VIEWER (K261465) | INDIGO TECHNOLOGIES | 2026-07-06 |
| MeVis AVM Contour (K260576) | MeVis Medical Solutions AG | 2026-06-30 |
| MiPACS V5 (1.0.0) (K260231) | Apryse Software Corp | 2026-06-25 |
| Perfusion Measurement Platform v1 (K253421) | Quantified Imaging Limited | 2026-06-22 |
| 2D Hip Planning Software (K261352) | One Ortho | 2026-06-08 |
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 |