Orthopedic Computer Controlled Surgical System
The Orthopedic Computer Controlled Surgical System is a robotically-assisted surgical system used for pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision, specifically as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty. Classified as FDA Class 2 under regulation 21 CFR 882.4560 within the Neurology medical specialty and reviewed by the Orthopedic panel, it requires a 510(k) premarket notification. The product code is OJP. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OJP
- Device Class
- FDA class 2
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150741 | TSolution One w/ACG surgical System | Oct 22, 2015 | Substantially Equivalent | THINK Surgical, Inc. |
| K140585 | CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM | Aug 18, 2014 | Substantially Equivalent | Curexo Technology Corporation |
| K140038 | DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM | May 27, 2014 | Substantially Equivalent | Curexo Technology Corporation |
| K072629 | DIGIMATCH ROBODOC SURGICAL SYSTEM | Aug 06, 2008 | Substantially Equivalent | Integrated Surgical Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.