Cleared Traditional

K142490 - ProxiFuse Hammer Toe Device

K142490 is an FDA 510(k) clearance for ProxiFuse Hammer Toe Device, manufactured by Cartiva, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K142490 · Cartiva, Inc. · Orthopedic device
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Dec 2014
Decision
102d
Days
Class 2
Risk

K142490 is an FDA 510(k) clearance for the ProxiFuse Hammer Toe Device. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Cartiva, Inc. (Alpharetta, US). The FDA issued a Cleared decision on December 15, 2014 after a review of 102 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 Cartiva, Inc. devices

FDA 510(k) Submission Details - K142490

510(k) Number K142490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2014
Decision Date December 15, 2014
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
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 726
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K142490.
Cannulated Screw System
K143460 · Wrightmedicaltechnologyinc · Jan 2015
Arthrex Low Profile Screws
K143614 · Arthrex, Inc. · Jan 2015
3.Omm Biomet Cannulated Screw System
K143188 · Biomet Manufacturing Corp · Dec 2014
PhaLinx Hammertoe System
K142585 · Wrightmedicaltechnologyinc · Nov 2014
Biomet Headless Compression and Twist-off Screws
K142658 · Biomet Manufacturing Corp · Nov 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442 · Zimmer, Inc. · Oct 2014