HTY · Class II · 21 CFR 888.3040

FDA Product Code HTY: Pin, Fixation, Smooth

FDA product code HTY covers smooth fixation pins used in orthopedic and trauma surgery.

These thin, smooth Kirschner wires and Steinmann pins are used to temporarily or definitively stabilize fracture fragments, guide cannulated screws, and fix small bones of the hand, wrist, and foot. Their smooth surface allows removal without disrupting surrounding tissue after healing.

HTY devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Arthrex, Inc., OSSIO , Ltd. and Synthes (Usa).

205
Total
205
Cleared
113d
Avg days
1977
Since
205 devices
49–72 of 205
Cleared Apr 17, 2015
ProCinch Adjustable Loop Device
K150416
Stryker Endoscopy
Orthopedic · 58d
Cleared Apr 09, 2015
Arthrex Blunt Tip Screws with Fiber Tape
K143702
Arthrex, Inc.
Orthopedic · 106d
Cleared Feb 19, 2015
LYNC intramedullary implant
K143049
Novastep
Orthopedic · 119d
Cleared Feb 06, 2015
Kirschner Wires, Steinmann Pins
K143618
Zimmer, Inc.
Orthopedic · 49d
Cleared Jan 27, 2015
Stryker SonicPin System, Stryker SonicAnchor System
K143063
Stryker Trauma GmbH
Orthopedic · 95d
Cleared Oct 24, 2014
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
K141714
Wrightmedicaltechnologyinc
Orthopedic · 121d
Cleared Sep 12, 2014
C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES
K142134
Conmed Corporation, Largo
Orthopedic · 39d
Cleared Aug 21, 2014
INTRAOSSEOUS FIXATION SYSTEM
K141004
Orthohelix Surgical Designs, Inc.
Orthopedic · 125d
Cleared Jul 18, 2014
ARTHREX PIP DART
K141577
Arthrex, Inc.
Orthopedic · 35d
Cleared Apr 11, 2014
INION FREEDOMPIN
K133932
Inion OY
Orthopedic · 109d
Cleared Feb 10, 2014
TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS
K133477
Synchro Medical
Orthopedic · 90d
Cleared Jan 22, 2014
ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
K133950
Bioretec, Ltd.
Orthopedic · 30d
Cleared Jan 09, 2014
HAMMERLOCK 2
K133520
Biomedical Enterprises, Inc.
Orthopedic · 55d
Cleared Oct 23, 2013
WMT IMPLANTABLE K-WIRE
K132895
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Oct 16, 2013
SMOOTH OR THREADED METALLIC BONE FASTENER
K131640
Biomedical Ent., Inc.
Orthopedic · 134d
Cleared May 17, 2013
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM
K130105
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 122d
Cleared Mar 15, 2013
X-FIX DYNAMIC EXTERNAL DISTRACTOR
K122415
Arex USA, LLC
Orthopedic · 219d
Cleared Jun 04, 2012
TRILLIANT SURGICAL K-WIRES
K121008
Trilliant Surgical, Ltd.
Orthopedic · 62d
Cleared Apr 24, 2012
APEX KIRSCHNER WIRES AND STEINMANN PINS
K121004
Apex Tools & Orthopedics Co.
Orthopedic · 21d
Cleared Apr 17, 2012
INTRAOSSEOUS FIXATION SYSTEM
K120165
Orthohelix Surgical Designs, Inc.
Orthopedic · 89d
Cleared Mar 20, 2012
NEWDEAL INTERPHALANGEAL IMPLANT
K103623
Newdeal Sas
Orthopedic · 466d
Cleared Dec 19, 2011
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
K112990
Arthrex, Inc.
Orthopedic · 74d
Cleared Dec 12, 2011
ARROW-LOK DIGITAL SYSTEM
K112675
Arrowhead Medical Device Technologies, LLC
Orthopedic · 89d
Cleared Nov 17, 2011
MEMOMETAL INTRA-MEDULLARY BONE FASTENER
K112197
Memometal Technologies
Orthopedic · 108d