Cleared Traditional

K240175 - Tigon Medical Fractures

K240175 is an FDA 510(k) clearance for Tigon Medical Fractures, manufactured by Tigon Medical. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K240175 · Tigon Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
280d
Days
Class 2
Risk

K240175 is an FDA 510(k) clearance for the Tigon Medical Fractures, Instability, and Reconstruction (FIRE). Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Tigon Medical (Millersville, US). The FDA issued a Cleared decision on October 29, 2024 after a review of 280 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 Tigon Medical devices

FDA 510(k) Submission Details - K240175

510(k) Number K240175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2024
Decision Date October 29, 2024
Days to Decision 280 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
158d slower than avg
Panel avg: 122d · This submission: 280d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K240175.
Arthrex SS VAL and VAL KreuLock™ Compression Screw System
K243195 · Arthrex, Inc. · Jan 2025
Locking Screw,CoCrMo
K242348 · Double Medical Technology, Inc. · Dec 2024
OsteoCoil™ Nitinol Compression System (Multiple Component PNs)
K233567 · Flower Orthopedics Corporation Dba Conventus Flower Ortho · Nov 2024
OsteoCentric Technologies Cannulated Fasteners and Nuts
K242691 · OsteoCentric Technologies · Oct 2024
Treace Medical Concepts (TMC) Screw Fixation System
K242671 · Treace Medical Concepts, Inc. · Oct 2024
Arthrex VAL and VAL KreuLock™ Compression Screw System
K241592 · Arthrex, Inc. · Aug 2024