FDA product code OJP: Orthopedic Computer Controlled Surgical System
OJP is the FDA product code for orthopedic computer controlled surgical system. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel. FDA has cleared 4 510(k) submissions under OJP, from 3 different applicants. The average 510(k) review took 210 days (median 188).
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).
Classification
| Field | Value |
|---|---|
| Device name | Orthopedic Computer Controlled Surgical System |
| Device class | Class II |
| Regulation | 21 CFR 882.4560 |
| Review panel | OR — Orthopedic |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OJP clearance
Top OJP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Curexo Technology Corporation | 2 | 2014-08-18 |
| THINK Surgical, Inc. | 1 | 2015-10-22 |
| Integrated Surgical Systems, Inc. | 1 | 2008-08-06 |
Most recent OJP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150741 | THINK Surgical, Inc. | TSolution One w/ACG surgical System | 2015-10-22 | 213 |
| K140585 | Curexo Technology Corporation | CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM | 2014-08-18 | 164 |
| K140038 | Curexo Technology Corporation | DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM | 2014-05-27 | 140 |
| K072629 | Integrated Surgical Systems, Inc. | DIGIMATCH ROBODOC SURGICAL SYSTEM | 2008-08-06 | 324 |
Recalls for OJP devices
openFDA lists no recalls for product code OJP.
Frequently asked questions
What is FDA product code OJP?
OJP is the FDA product code for orthopedic computer controlled surgical system. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel.
What device class is OJP?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code OJP?
Across 4 cleared submissions the average was 210 days from receipt to decision (median 188).
Which companies have the most OJP clearances?
Curexo Technology Corporation (2); THINK Surgical, Inc. (1); Integrated Surgical Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OJP
- Run a recall and safety report across every OJP manufacturer
- Watch product code OJP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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