Cleared Special

K121004 - APEX KIRSCHNER WIRES AND STEINMANN PINS

K121004 is an FDA 510(k) clearance for APEX KIRSCHNER WIRES AND STEINMANN PINS, manufactured by Apex Tools & Orthopedics Co.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Special 510(k) pathway after a 21-day FDA review.

K121004 · Apex Tools & Orthopedics Co. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
21d
Days
Class 2
Risk

K121004 is an FDA 510(k) clearance for the APEX KIRSCHNER WIRES AND STEINMANN PINS. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Apex Tools & Orthopedics Co. (Washington, US). The FDA issued a Cleared decision on April 24, 2012 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K121004

510(k) Number K121004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2012
Decision Date April 24, 2012
Days to Decision 21 days
Submission Type Special
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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 Peers - HTY Pin, Fixation, Smooth

All 198
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K121004.
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM
K130105 · Depuy Mitek, A Johnson & Johnson Company · May 2013
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K122415 · Arex USA, LLC · Mar 2013
TRILLIANT SURGICAL K-WIRES
K121008 · Trilliant Surgical, Ltd. · Jun 2012
INTRAOSSEOUS FIXATION SYSTEM
K120165 · Orthohelix Surgical Designs, Inc. · Apr 2012
NEWDEAL INTERPHALANGEAL IMPLANT
K103623 · Newdeal Sas · Mar 2012
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
K112990 · Arthrex, Inc. · Dec 2011
K121004 · APEX KIRSCHNER WIRES AND STEINMANN PINS
Download PDF FDA Summary Apex Tools & Orthoped…