Cleared Traditional

K120651 - STABILIZ FIXATION SYSTEM

K120651 is an FDA 510(k) clearance for STABILIZ FIXATION SYSTEM, manufactured by Stabiliz Orthopaedics, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K120651 · Stabiliz Orthopaedics, LLC · Orthopedic device
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Nov 2012
Decision
270d
Days
Class 2
Risk

K120651 is an FDA 510(k) clearance for the STABILIZ FIXATION SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Stabiliz Orthopaedics, LLC (Philadelphia, US). The FDA issued a Cleared decision on November 27, 2012 after a review of 270 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Stabiliz Orthopaedics, LLC devices

FDA 510(k) Submission Details - K120651

510(k) Number K120651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2012
Decision Date November 27, 2012
Days to Decision 270 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 122d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1051
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K120651.
MAXLOCK EXTREME SYSTEM MODEL MXL
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K120787 · Merete Medical GmbH · Nov 2012
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K120409 · CarboFix Orthopedics , Ltd. · Nov 2012
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K121494 · Aap Implantate AG · Nov 2012