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
25–48 of 205
Cleared Jun 29, 2020
Arthrex DynaNite K-Wire
K200068
Arthrex, Inc.
Orthopedic · 168d
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 Dec 14, 2017
WishBone K-Wire System
K173013
Wishbone Medical, Inc.
Orthopedic · 78d
Cleared Nov 16, 2017
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
K173051
Orthofix Srl
Orthopedic · 49d
Cleared Jul 20, 2017
dynaMX Intramedullary Implant
K170326
Arthrex, Inc.
Orthopedic · 168d
Cleared Jun 20, 2017
Stryker SonicPin System
K170418
Stryker Trauma GmbH
Orthopedic · 127d
Cleared May 08, 2017
Precifit Medical Kirschner Wires
K163327
Precifit Medical, Ltd.
Orthopedic · 161d
Cleared Sep 16, 2016
Syntorr K-wire and Pin System
K161489
Syntorr, Inc.
Orthopedic · 107d
Cleared Jun 01, 2016
Additive Orthopaedics Hammertoe Correction System
K160264
Additive Orthopaedics, LLC
Orthopedic · 120d
Cleared Apr 26, 2016
StarFuse Interphalangeal Pin
K160194
Phalanx Innovations
Orthopedic · 90d
Cleared Mar 09, 2016
S-Wire
K152662
Spinal Resources, Inc.
Orthopedic · 174d
Cleared Feb 01, 2016
In2Bones Kirschner wire
K153204
In2bones Sas
Orthopedic · 89d
Cleared Jan 13, 2016
IFS Fixation Scaffold System
K152627
Metric Medical Devices, Inc.
Orthopedic · 120d
Cleared Dec 30, 2015
Bio2 Fusion Implant System
K151876
Bio2 Technologies, Inc.
Orthopedic · 174d
Cleared May 29, 2015
opti-Toe
K142478
Graham Medical Technologies, LLC (D.B.A.Gramedica)
Orthopedic · 268d
Cleared May 01, 2015
Rush Medullary Pins
K150626
Zimmer, Inc.
Orthopedic · 51d