Cleared Traditional

K162341 - Stryker OrthoMap Precision Knee system

K162341 is an FDA 510(k) clearance for Stryker OrthoMap Precision Knee system, manufactured by Stryker Leibinger GmbH & Co KG. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K162341 · Stryker Leibinger GmbH & Co KG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
51d
Days
Class 2
Risk

K162341 is an FDA 510(k) clearance for the Stryker OrthoMap Precision Knee system. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on October 12, 2016 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Leibinger GmbH & Co KG devices

FDA 510(k) Submission Details - K162341

510(k) Number K162341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 122d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLO Device Classification - Class 2, Special Controls

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Biologics Consulting Group, Inc.
Calley Herzog

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 381
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K162341.
Navigated Instrument System
K162921 · Orthofix, Inc. · Mar 2017
TSolution One Surgical System Model 210
K170430 · THINK Surgical, Inc. · Mar 2017
Stryker OrthoMap Versatile Hip System
K162937 · Stryker Corporation · Feb 2017
TSolution One Cup1 Surgical System
K162195 · THINK Surgical, Inc. · Sep 2016
Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
K153700 · Aesculap Implant Systems, LLC · Jul 2016
Navio
K160537 · Blue Belt Technologies, Inc. · May 2016