Cleared Traditional

SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) (K100112) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100112 · Sonoma Orthopedic Products, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2010
Decision
257d
Days
Class 2
Risk

K100112 is an FDA 510(k) clearance for the SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=L.... Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Sonoma Orthopedic Products, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on September 28, 2010 after a review of 257 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sonoma Orthopedic Products, Inc. devices

Submission Details

510(k) Number K100112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2010
Decision Date September 28, 2010
Days to Decision 257 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 122d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K100112.
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
K103002 · Synthes (Usa) · Mar 2011
T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
K102992 · Howmedica Osteonics Corp. · Dec 2010
ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS
K101622 · Zimmer, Inc. · Oct 2010
T2 GREATER TROCHANTER NAIL
K101438 · Howmedica Osteonics Corp. · Jun 2010
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
K100238 · DePuy Orthopaedics, Inc. · May 2010
SURESHOT TAN NAILS AND ACCESSORIES
K092748 · Smith & Nephew, Inc. · Apr 2010