Cleared Traditional

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) (K240175) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 410
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