Tier 1regulatory_clearanceApprovedev-us-fda-k251971

FDA 510(k) K251971, RPS Primary TKA Software and RPS Console system

U.S. Food and Drug Administration (CDRH 510(k) database)

Summary

Applicant Stryker Instruments, Portage Michigan. Received 26 June 2025, decision 25 September 2025, substantially equivalent, product code OLO, regulation 21 CFR 882.4560 orthopedic stereotaxic instrument. Covers RPS Primary TKA Software, RPS Console, RPS Saw One and associated accessories.

Supporting location 510(k) database record for K251971

Open source

Published

25 Sep 2025

Applicable from

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Accessed

27 Aug 2026

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No current answer cites this record.