Cleared Traditional

K120597 - KOMPREDA

K120597 · Custom Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
430d
Days
-
Risk

K120597 is an FDA 510(k) clearance for the KOMPREDA. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Custom Spine, Inc. (Parsippany, US). The FDA issued a Cleared decision on May 3, 2013 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Custom Spine, Inc. devices

FDA 510(k) Submission Details - K120597

510(k) Number K120597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2012
Decision Date May 03, 2013
Days to Decision 430 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
308d slower than avg
Panel avg: 122d · This submission: 430d
Pathway characteristics
Predicate-based equivalence.

MRW Device Classification - Class 0,

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 59
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K120597.
INTEGRA FACET FIXATION SYSTEM
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K130863 · Spinal USA · Aug 2013
FACET FIXX
K131417 · Nexxt Spine, LLC · Jul 2013
ZYGAFIX SPINAL FACET SCREW SYSTEM
K123932 · X-Spine Systems, Inc. · May 2013
ILLICO FS FACET FIXATION SYSTEM
K123218 · Alphatec Spine, Inc. · Nov 2012
Typhoon(TM) Facet Screw Fixation System
K121850 · Choicespine, LP · Sep 2012