Clearance Summary
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer received FDA 510(k) clearance under submission number K251971, sponsored by Stryker Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-09-25.
- Submission: K251971
- Applicant / Sponsor: Stryker Instruments
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2025-09-25
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.