Cleared Traditional

K051856 - TRANS1 FACET SCREWS

K051856 · Trans1 Incorporated · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
80d
Days
-
Risk

K051856 is an FDA 510(k) clearance for the TRANS1 FACET SCREWS. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Trans1 Incorporated (Wilmington, US). The FDA issued a Cleared decision on September 26, 2005 after a review of 80 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 - K051856

510(k) Number K051856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2005
Decision Date September 26, 2005
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 K051856.
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02
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K051949 · Triage Medical, Inc. · Aug 2005
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K043351 · Triage Medical, Inc. · Feb 2005
STRYKER SPINE OASYS BONE SCREW
K031657 · Howmedica Osteonics Corp. · Aug 2003
K051856 · TRANS1 FACET SCREWS
Download PDF FDA Summary Trans1 Incorporated