Cleared Traditional

RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer

K251971 · Stryker Instruments · Orthopedic

Sep 2025

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K251971 is an FDA 510(k) clearance for the RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on September 25, 2025, 91 days after receiving the submission on June 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K251971 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2025
Decision Date	September 25, 2025
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.