Cleared Traditional

K121936 - NAVIOPFS

K121936 is an FDA 510(k) clearance for NAVIOPFS, manufactured by Blue Belt Technologies, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K121936 · Blue Belt Technologies, Inc. · Orthopedic device
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Nov 2012
Decision
151d
Days
Class 2
Risk

K121936 is an FDA 510(k) clearance for the NAVIOPFS. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Blue Belt Technologies, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on November 30, 2012 after a review of 151 days - an extended review 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: 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 Blue Belt Technologies, Inc. devices

FDA 510(k) Submission Details - K121936

510(k) Number K121936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2012
Decision Date November 30, 2012
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
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 Peers - OLO Orthopedic Stereotaxic Instrument

All 381
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K121936.
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748 · Smith & Nephew, Inc. · Aug 2013
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
K124004 · Medtronic Navigation, Inc. · Mar 2013
NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
K122742 · Nuvasive, Inc. · Dec 2012
NAVIGATION SOFTWARE HIP-UNIVERSAL
K122011 · Brainlab AG · Nov 2012
VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
K120867 · Medos International SARL · Sep 2012
BENDINI(TM) SPINAL ROD BENDING SYSTEM
K111811 · Nuvasive, Inc. · Dec 2011