Cleared Traditional

Stryker OrthoMap Precision Knee system

K162341 · Stryker Leibinger GmbH & Co KG · Orthopedic

Oct 2016

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K162341 is an FDA 510(k) clearance for the Stryker OrthoMap Precision Knee system, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on October 12, 2016, 51 days after receiving the submission on August 22, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K162341 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 2016
Decision Date	October 12, 2016
Days to Decision	51 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.