Cleared Traditional

K160194 - StarFuse Interphalangeal Pin

K160194 is an FDA 510(k) clearance for StarFuse Interphalangeal Pin, manufactured by Phalanx Innovations. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K160194 · Phalanx Innovations · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K160194

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
Combination Product No
PCCP Authorized No
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.

HTY Device Classification - Class 2, Special Controls

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 Consultant

Wagoner Consulting, LLC
Cheryl Wagoner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HTY Pin, Fixation, Smooth

All 196
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K160194.
Precifit Medical Kirschner Wires
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Syntorr K-wire and Pin System
K161489 · Syntorr, Inc. · Sep 2016
Additive Orthopaedics Hammertoe Correction System
K160264 · Additive Orthopaedics, LLC · Jun 2016
S-Wire
K152662 · Spinal Resources, Inc. · Mar 2016
In2Bones Kirschner wire
K153204 · In2bones Sas · Feb 2016
IFS Fixation Scaffold System
K152627 · Metric Medical Devices, Inc. · Jan 2016