Cleared Traditional

K052043 - 3.8MM CS FACET COMPRESSION DEVICE

K052043 · Triage Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
81d
Days
-
Risk

K052043 is an FDA 510(k) clearance for the 3.8MM CS FACET COMPRESSION DEVICE. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Triage Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on October 17, 2005 after a review of 81 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K052043

510(k) Number K052043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2005
Decision Date October 17, 2005
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 78
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K052043.
CHAMELEON FIXATION SYSTEM
K071420 · Spinefrontier, Inc. · Jan 2008
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02
K062391 · Triage Medical, Inc. · Sep 2006
US SPINE FACET FIXATION SYSTEM
K061041 · Us Spine · Jun 2006
TRANS1 FACET SCREWS
K051856 · Trans1 Incorporated · Sep 2005
4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
K051949 · Triage Medical, Inc. · Aug 2005
4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N
K043351 · Triage Medical, Inc. · Feb 2005
K052043 · 3.8MM CS FACET COMPRESSION DEVICE
Download PDF FDA Summary Triage Medical, Inc.