Cleared Traditional

Sonoma Fibula Repair System (K142945) - FDA 510(k) Clearance

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

K142945 · Sonoma Orthopedic Products, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
104d
Days
Class 2
Risk

K142945 is an FDA 510(k) clearance for the Sonoma Fibula Repair System. 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 January 22, 2015 after a review of 104 days - within the typical 510(k) review window.

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 K142945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2014
Decision Date January 22, 2015
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 K142945.
Affixus Tibial Nailing System
K150867 · Biomet, Inc. · Jun 2015
ITST Intertrochanteric/Subtrochanteric Fixation System
K143321 · Zimmer, Inc. · May 2015
MICRONAIL Distal Radius System
K150073 · Wrightmedicaltechnologyinc · Feb 2015
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
K142281 · Zimmer, Inc. · Oct 2014
VALOR Hindfoot Fusion Nail System
K142602 · Wrightmedicaltechnologyinc · Oct 2014
SYNTHES SYNSONIC ULNA NAIL
K131984 · Synthes (Usa) · Mar 2014