Cleared Traditional

StarFuse Interphalangeal Pin (K160194) - FDA 510(k) Clearance

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

K160194 · Phalanx Innovations · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
90d
Days
Class 2
Risk

K160194 is an FDA 510(k) clearance for the StarFuse Interphalangeal Pin. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Phalanx Innovations (Marietta, US). The FDA issued a Cleared decision on April 26, 2016 after a review of 90 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 Phalanx Innovations devices

Submission Details

510(k) Number K160194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date April 26, 2016
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 68
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K160194.
Footmotion HammerToe
K172485 · Newclip Technics · Mar 2018
DIP Arthrodesis System
K173616 · In2bones Sas · Jan 2018
dynaMX Intramedullary Implant
K170326 · Arthrex, Inc. · Jul 2017
Rush Medullary Pins
K150626 · Zimmer, Inc. · May 2015
Arthrex Blunt Tip Screws with Fiber Tape
K143702 · Arthrex, Inc. · Apr 2015
Kirschner Wires, Steinmann Pins
K143618 · Zimmer, Inc. · Feb 2015