Cleared Traditional

K111550 - SONOMA FASTRAC CLAVICLE FRACTURE REPAIR...

K111550 is an FDA 510(k) clearance for SONOMA FASTRAC CLAVICLE FRACTURE REPAIR..., manufactured by Sonoma Orthopedic Products, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K111550 · Sonoma Orthopedic Products, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
77d
Days
Class 2
Risk

K111550 is an FDA 510(k) clearance for the SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=D.... 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 August 19, 2011 after a review of 77 days - a notably fast clearance 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: 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 Sonoma Orthopedic Products, Inc. devices

FDA 510(k) Submission Details - K111550

510(k) Number K111550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2011
Decision Date August 19, 2011
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

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 379
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K111550.
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
K120083 · Synthes (Usa) · Feb 2012
OSLEOBRIDGE IDSF SPACER CONECTOR
K113303 · Merete Medical GmbH · Dec 2011
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
K111891 · Synthes USA Products, LLC · Nov 2011
T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
K112059 · Stryker · Aug 2011
TRIGEN LOW PROFILE BONE SCREW
K111025 · Smith & Nephew, Inc. · Jul 2011
UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
K111444 · DePuy Orthopaedics, Inc. · Jun 2011