Cleared Traditional

Kirschner Wires, Steinmann Pins (K143618) - FDA 510(k) Clearance

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

K143618 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
49d
Days
Class 2
Risk

K143618 is an FDA 510(k) clearance for the Kirschner Wires, Steinmann Pins. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 6, 2015 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K143618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2014
Decision Date February 06, 2015
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 67
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K143618.
dynaMX Intramedullary Implant
K170326 · Arthrex, Inc. · Jul 2017
Rush Medullary Pins
K150626 · Zimmer, Inc. · May 2015
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K143702 · Arthrex, Inc. · Apr 2015
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
K141714 · Wrightmedicaltechnologyinc · Oct 2014
ARTHREX PIP DART
K141577 · Arthrex, Inc. · Jul 2014
WMT IMPLANTABLE K-WIRE
K132895 · Wrightmedicaltechnologyinc · Oct 2013