Cleared Traditional

K092609 - SYNTHES 3.5 MM AND 4.55 MM CURVED NARRO...

K092609 is the FDA 510(k) clearance for SYNTHES 3.5 MM AND 4.55 MM CURVED NARRO... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K092609 · Synthes (Usa) · Orthopedic device
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Nov 2009
Decision
84d
Days
Class 2
Risk

K092609 is an FDA 510(k) clearance for the SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES.... 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 84 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 K092609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2009
Decision Date November 17, 2009
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 K092609.
INTEGRA TOTAL WRIST FUSION SYSTEM
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AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
K092178 · Howmedica Osteonics Corp. · Nov 2009
SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS
K092556 · 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
SYNTHES LOCKING HAND PLATES
K092247 · Synthes (Usa) · Sep 2009