Cleared Traditional

K123093 - STABILINK MIS SPINAL FIXATION SYSTEM

K123093 is an FDA 510(k) clearance for STABILINK MIS SPINAL FIXATION SYSTEM, manufactured by Southern Spine, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K123093 · Southern Spine, LLC · Orthopedic device
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Dec 2012
Decision
79d
Days
Class 2
Risk

K123093 is an FDA 510(k) clearance for the STABILINK MIS SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Southern Spine, LLC (Alpharetta, US). The FDA issued a Cleared decision on December 20, 2012 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Southern Spine, LLC devices

FDA 510(k) Submission Details - K123093

510(k) Number K123093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2012
Decision Date December 20, 2012
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 322
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K123093.
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K123656 · Medtronic Sofamor Danek USA, Inc. · Feb 2013
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K121877 · Exactech, Inc. · Feb 2013
SPINEOLOGY SPINOUS PROCESS PLATE
K123232 · Spineology, Inc. · Feb 2013
VERTEX RECONSTRUCTION SYSTEM
K123568 · Medtronic Sofamor Danek USA, Inc. · Dec 2012
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
K121725 · Pioneer Surgical Technology, Inc. · Nov 2012
RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
K122292 · Reliance Medical Systems, LLC · Oct 2012