Cleared Traditional

K130731 - STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW

K130731 is an FDA 510(k) clearance for STABILIZ FIXATION SYSTEM - SPL LOCKING ..., 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 123-day FDA review.

K130731 · Stabiliz Orthopaedics, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
123d
Days
Class 2
Risk

K130731 is an FDA 510(k) clearance for the STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW. 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 (Exton, US). The FDA issued a Cleared decision on July 19, 2013 after a review of 123 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K130731

510(k) Number K130731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2013
Decision Date July 19, 2013
Days to Decision 123 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
1d slower than avg
Panel avg: 122d · This submission: 123d
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 1314
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K130731.
INTEGRA TITANIUM BONE WEDGE
K131360 · Ascension Orthopedic · Aug 2013
I.T.S. EXTREMITY FIXATION SYSTEMS
K131722 · I.T.S. GmbH · Aug 2013
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
K123347 · Normed Medizin-Technik GmbH · Aug 2013
ARTHREX DISTAL RADIUS PLATE SYSTEM
K131474 · Arthrex, Inc. · Jul 2013
EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
K131480 · Emerge Medical · Jul 2013
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
K131670 · Biomet, Inc. · Jul 2013
K130731 · STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW
Download PDF FDA Summary Stabiliz Orthopaedics…