Cleared Traditional

K061041 - US SPINE FACET FIXATION SYSTEM

K061041 · Us Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
66d
Days
-
Risk

K061041 is an FDA 510(k) clearance for the US SPINE FACET FIXATION SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Us Spine (Apple Valley, US). The FDA issued a Cleared decision on June 19, 2006 after a review of 66 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 - K061041

510(k) Number K061041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2006
Decision Date June 19, 2006
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
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 K061041.
TRANS1 FACET SCREW
K073515 · Trans1 Incorporated · Mar 2008
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
3.8MM CS FACET COMPRESSION DEVICE
K052043 · Triage Medical, Inc. · Oct 2005
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
K061041 · US SPINE FACET FIXATION SYSTEM
Download PDF FDA Summary Us Spine