Stryker Instruments · Class II · Cleared Sep 25, 2025
| K-number | K251971 |
| Device name | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer |
| Applicant | Stryker Instruments |
| Product code | OLO |
| Device class | Class II |
| Decision date | Sep 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The RPS Primary TKA Software is a robotic precision system intended to assist surgeons during total knee arthroplasty (TKA) procedures by providing software-defined spatial boundaries for orientation and reference information to rigid anatomical structures. The system consists of software, console, saw, cable, oscillating tip cartridge, cart attachment, and pointer components that work together to guide orthopedic surgical procedures where stereotactic surgery is appropriate and rigid bony anatomical landmarks can be identified.
Not stated in this summary.
Not stated.
The device is classified as a stereotaxic instrument (21 CFR 882.4560, Class II, product code OLO) and is substantially equivalent to legally marketed predicate devices that predate the Medical Device Amendments of 1976. The application of robotic guidance technology to provide spatial boundaries and orientation reference during TKA procedures does not raise new questions of safety or effectiveness when compared to predicate stereotaxic instruments used in orthopedic surgery.
View the full FDA submission: accessdata.fda.gov