Cleared Traditional

K150443 - ToeTac Hammertoe Fixation System

K150443 is an FDA 510(k) clearance for ToeTac Hammertoe Fixation System, manufactured by Restore Surgical, LLC Dba Instratek. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K150443 · Restore Surgical, LLC Dba Instratek · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
104d
Days
Class 2
Risk

K150443 is an FDA 510(k) clearance for the ToeTac Hammertoe Fixation System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Restore Surgical, LLC Dba Instratek (Houston, US). The FDA issued a Cleared decision on June 4, 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 888.3040 - 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 - K150443

510(k) Number K150443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2015
Decision Date June 04, 2015
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 Peers - HWC Screw, Fixation, Bone

All 1042
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K150443.
Monster Screw System
K151418 · Paragon 28 · Jul 2015
SMV Scientific Bone Screws
K150981 · Smv Scientific · Jun 2015
Sonoma Cancellous Bone Screw and Washer
K150376 · Sonoma Orthopedics Products, Inc. · Jun 2015
Biomet Microfixation RibFix Blu Thoracic Fixation System
K151173 · Biomet Microfixation · May 2015
Arthrex RetroFusion Screw
K151078 · Arthrex, Inc. · May 2015
Life Spine Cannulated Screws
K150126 · Life Spine, Inc. · May 2015