Cleared Traditional

K092556 - SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN N...

K092556 is the FDA 510(k) clearance for SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN N... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K092556 · Synthes (Usa) · Orthopedic device
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Nov 2009
Decision
89d
Days
Class 2
Risk

K092556 is an FDA 510(k) clearance for the SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on November 17, 2009 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K092556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2009
Decision Date November 17, 2009
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K092556.
SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES
K091644 · Synthes (Usa) · Dec 2009
INTEGRA TOTAL WRIST FUSION SYSTEM
K093163 · Integra LifeSciences Corporation · Dec 2009
AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
K092178 · Howmedica Osteonics Corp. · Nov 2009
SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)
K092609 · Synthes (Usa) · Nov 2009
DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM
K092317 · Deroyal Industries, Inc. · Nov 2009
ANKLE ARTHRODESIS PLATE SYSTEM
K090139 · Tornier, Inc. · Oct 2009