Cleared Traditional

K083009 - ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE

K083009 is an FDA 510(k) clearance for ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, 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 133-day FDA review.

K083009 · Stryker Leibinger GmbH & Co KG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
133d
Days
Class 2
Risk

K083009 is an FDA 510(k) clearance for the ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000. 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 Baden-Wurttemberg, DE). The FDA issued a Cleared decision on February 19, 2009 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Leibinger GmbH & Co KG devices

FDA 510(k) Submission Details - K083009

510(k) Number K083009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2008
Decision Date February 19, 2009
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
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.