Cleared Traditional

K171018 - Axis Charcot Fixation System, 4.5 to 8.5mm Screw System

K171018 is an FDA 510(k) clearance for Axis Charcot Fixation System, manufactured by Extremity Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K171018 · Extremity Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
99d
Days
Class 2
Risk

K171018 is an FDA 510(k) clearance for the Axis Charcot Fixation System, 4.5 to 8.5mm Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on July 13, 2017 after a review of 99 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.

View all Extremity Medical, LLC devices

FDA 510(k) Submission Details - K171018

510(k) Number K171018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2017
Decision Date July 13, 2017
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
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 986
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K171018.
TalarLift STS
K170624 · Fusion Orthopedics, LLC · Aug 2017
FuzeFix Screw System
K170038 · Fusion Orthopedics, LLC · Aug 2017
Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
K162153 · Ascension Orthopedics · Jul 2017
Hammertoe Correction System
K171448 · Life Spine, Inc. · Jul 2017
Cannulated Screws Neoortho
K162874 · Neoortho Produtos Ortopedicos S/A · Jun 2017
Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
K170571 · Tyber Medical, LLC · Jun 2017