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).

204
Total
204
Cleared
114d
Avg days
1977
Since
204 devices
25–48 of 204
Cleared Mar 06, 2020
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
K190652
OSSIO , Ltd.
Orthopedic · 359d
Cleared Jul 23, 2019
Hammertoe Truss System (HTS)
K190926
4Web, Inc.
Orthopedic · 105d
Cleared May 03, 2019
Arthrex DynaNite® PIP (Hammertoe) Implant
K190287
Arthrex, Inc.
Orthopedic · 81d
Cleared Jan 25, 2019
HammerToe Compression System
K183228
Paragon 28, Inc.
Orthopedic · 66d
Cleared Jan 10, 2019
OSSIO™ Pin Product Family
K181180
OSSIO , Ltd.
Orthopedic · 253d
Cleared May 18, 2018
A.M. Surgical Intramedullary Fixation Device
K180087
A.M. Surgical, Inc.
Orthopedic · 126d
Cleared Mar 05, 2018
HammerTube System
K171715
Paragon 28
Orthopedic · 269d
Cleared Mar 02, 2018
Footmotion HammerToe
K172485
Newclip Technics
Orthopedic · 197d
Cleared Jan 19, 2018
DIP Arthrodesis System
K173616
In2bones Sas
Orthopedic · 58d
Cleared Jul 20, 2017
dynaMX Intramedullary Implant
K170326
Arthrex, Inc.
Orthopedic · 168d
Cleared May 01, 2015
Rush Medullary Pins
K150626
Zimmer, Inc.
Orthopedic · 51d
Cleared Apr 09, 2015
Arthrex Blunt Tip Screws with Fiber Tape
K143702
Arthrex, Inc.
Orthopedic · 106d
Cleared Feb 06, 2015
Kirschner Wires, Steinmann Pins
K143618
Zimmer, Inc.
Orthopedic · 49d
Cleared Oct 24, 2014
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
K141714
Wrightmedicaltechnologyinc
Orthopedic · 121d
Cleared Jul 18, 2014
ARTHREX PIP DART
K141577
Arthrex, Inc.
Orthopedic · 35d
Cleared Oct 23, 2013
WMT IMPLANTABLE K-WIRE
K132895
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Dec 19, 2011
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
K112990
Arthrex, Inc.
Orthopedic · 74d
Cleared Apr 28, 2011
PCL TIGHTROPE
K110123
Arthrex, Inc.
Orthopedic · 100d
Cleared Dec 28, 2010
ACL TIGHTROPE DOUBLE BUNDLE
K101837
Arthrex, Inc.
Orthopedic · 180d
Cleared Jun 23, 2010
ACL TIGHTROPE
K100652
Arthrex, Inc.
Orthopedic · 107d
Cleared Apr 02, 2010
STRYKER SONICPIN SYSTEM
K091955
Howmedica Osteonics Corp.
Orthopedic · 275d
Cleared Mar 06, 2007
ARTHREX CROSSPIN, MODEL AR-1964P
K063719
Arthrex, Inc.
Orthopedic · 81d
Cleared Nov 03, 2005
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT
K052736
Arthrex, Inc.
Orthopedic · 34d
Cleared May 27, 2005
ARTHREX BIO-PIN
K050259
Arthrex, Inc.
Orthopedic · 113d