Cleared Traditional

K150376 - Sonoma Cancellous Bone Screw and Washer

K150376 is an FDA 510(k) clearance for Sonoma Cancellous Bone Screw and Washer, manufactured by Sonoma Orthopedics Products, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K150376 · Sonoma Orthopedics Products, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
119d
Days
Class 2
Risk

K150376 is an FDA 510(k) clearance for the Sonoma Cancellous Bone Screw and Washer. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Sonoma Orthopedics Products, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on June 12, 2015 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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.

FDA 510(k) Submission Details - K150376

510(k) Number K150376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2015
Decision Date June 12, 2015
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 Consultant

Memphis Regulatory Consulting, LLC
Dawn Norman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 1042
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K150376.
OsteoMed Cannulated Screw System
K151021 · Osteomed Corp. · Jul 2015
Monster Screw System
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SMV Scientific Bone Screws
K150981 · Smv Scientific · Jun 2015
ToeTac Hammertoe Fixation System
K150443 · Restore Surgical, LLC Dba Instratek · Jun 2015
Biomet Microfixation RibFix Blu Thoracic Fixation System
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Arthrex RetroFusion Screw
K151078 · Arthrex, Inc. · May 2015