Cleared Traditional

K170038 - FuzeFix Screw System

K170038 is an FDA 510(k) clearance for FuzeFix Screw System, manufactured by Fusion Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K170038 · Fusion Orthopedics, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
214d
Days
Class 2
Risk

K170038 is an FDA 510(k) clearance for the FuzeFix Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Fusion Orthopedics, LLC (Mesa, US). The FDA issued a Cleared decision on August 7, 2017 after a review of 214 days - an extended review cycle.

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.

View all Fusion Orthopedics, LLC devices

FDA 510(k) Submission Details - K170038

510(k) Number K170038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2017
Decision Date August 07, 2017
Days to Decision 214 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
92d slower than avg
Panel avg: 122d · This submission: 214d
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 691
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170038.
BePOD® Foot Screws
K163148 · Fournitures Hospitalieres Industrie · Sep 2017
BePOD® EZ Weil Screws
K163710 · Fournitures Hospitalieres Industrie · Sep 2017
Medline UNITE® Snap-Off Screws
K170782 · Medline Industries, Inc. · Aug 2017
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
K171018 · Extremity Medical, LLC · Jul 2017
Hammertoe Correction System
K171448 · Life Spine, Inc. · Jul 2017
Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
K170571 · Tyber Medical, LLC · Jun 2017