OJP — Orthopedic Computer Controlled Surgical System Class II
Classification Details
- Product Code
- OJP
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Neurology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150741 | think surgical | TSolution One w/ACG surgical System | October 22, 2015 |
| K140585 | curexo technology corporation | CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM | August 18, 2014 |
| K140038 | curexo technology corporation | DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM | May 27, 2014 |
| K072629 | integrated surgical systems | DIGIMATCH ROBODOC SURGICAL SYSTEM | August 6, 2008 |