Cleared Traditional

Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System

K223767 · Stryker Leibinger GmbH & Co KG · Orthopedic

Feb 2023

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K223767 is an FDA 510(k) clearance for the Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Stryker Leibinger GmbH & Co KG (Freiburg Im Breisgau, DE). The FDA issued a Cleared decision on February 13, 2023, 60 days after receiving the submission on December 15, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K223767 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2022
Decision Date	February 13, 2023
Days to Decision	60 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.