Orthopedic Computer Controlled Surgical System
FDA product code OJP · Class II (moderate risk) · 21 CFR 882.4560 · Neurology
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).
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150741 | TSolution One w/ACG surgical SystemOJP · Traditional | THINK Surgical, Inc. | 10/22/2015SE |
| K140585 | CTC Tcat(R)-Tplan(R) Surgical SystemOJP · Traditional | Curexo Technology Corporation | 08/18/2014SE |
| K140038 | Digimatch Orthodoc Robodoc Encore Surgical SystemOJP · Traditional | Curexo Technology Corporation | 05/27/2014SE |
| K072629 | Digimatch Robodoc Surgical SystemOJP · Traditional | Integrated Surgical Systems, Inc. | 08/06/2008SE |