OJP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Orthopedic Computer Controlled Surgical System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Medical specialty
- Neurology
- FDA definition
- Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TSolution One w/ACG surgical System (K150741) | THINK Surgical, Inc. | 2015-10-22 |
| CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM (K140585) | Curexo Technology Corporation | 2014-08-18 |
| DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM (K140038) | Curexo Technology Corporation | 2014-05-27 |
| DIGIMATCH ROBODOC SURGICAL SYSTEM (K072629) | Integrated Surgical Systems, Inc. | 2008-08-06 |
Track OJP automatically
Every clearance here is in the API, with alerts when new ones post.