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
Cleared
Jun 29, 2020
Arthrex DynaNite K-Wire
Arthrex, Inc.
Orthopedic
168d
Cleared
Mar 06, 2020
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
OSSIO , Ltd.
Orthopedic
359d
Cleared
Jul 23, 2019
Hammertoe Truss System (HTS)
4Web, Inc.
Orthopedic
105d
Cleared
May 03, 2019
Arthrex DynaNite® PIP (Hammertoe) Implant
Arthrex, Inc.
Orthopedic
81d
Cleared
Jan 25, 2019
HammerToe Compression System
Paragon 28, Inc.
Orthopedic
66d
Cleared
Jan 10, 2019
OSSIO™ Pin Product Family
OSSIO , Ltd.
Orthopedic
253d
Cleared
May 18, 2018
A.M. Surgical Intramedullary Fixation Device
A.M. Surgical, Inc.
Orthopedic
126d
Cleared
Mar 05, 2018
HammerTube System
Paragon 28
Orthopedic
269d
Cleared
Mar 02, 2018
Footmotion HammerToe
Newclip Technics
Orthopedic
197d
Cleared
Jan 19, 2018
DIP Arthrodesis System
In2bones Sas
Orthopedic
58d
Cleared
Dec 14, 2017
WishBone K-Wire System
Wishbone Medical, Inc.
Orthopedic
78d
Cleared
Nov 16, 2017
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
Orthofix Srl
Orthopedic
49d
Cleared
Jul 20, 2017
dynaMX Intramedullary Implant
Arthrex, Inc.
Orthopedic
168d
Cleared
Jun 20, 2017
Stryker SonicPin System
Stryker Trauma GmbH
Orthopedic
127d
Cleared
May 08, 2017
Precifit Medical Kirschner Wires
Precifit Medical, Ltd.
Orthopedic
161d
Cleared
Sep 16, 2016
Syntorr K-wire and Pin System
Syntorr, Inc.
Orthopedic
107d
Cleared
Jun 01, 2016
Additive Orthopaedics Hammertoe Correction System
Additive Orthopaedics, LLC
Orthopedic
120d
Cleared
Apr 26, 2016
StarFuse Interphalangeal Pin
Phalanx Innovations
Orthopedic
90d
Cleared
Mar 09, 2016
S-Wire
Spinal Resources, Inc.
Orthopedic
174d
Cleared
Feb 01, 2016
In2Bones Kirschner wire
In2bones Sas
Orthopedic
89d
Cleared
Jan 13, 2016
IFS Fixation Scaffold System
Metric Medical Devices, Inc.
Orthopedic
120d
Cleared
Dec 30, 2015
Bio2 Fusion Implant System
Bio2 Technologies, Inc.
Orthopedic
174d
Cleared
May 29, 2015
opti-Toe
Graham Medical Technologies, LLC (D.B.A.Gramedica)
Orthopedic
268d
Cleared
May 01, 2015
Rush Medullary Pins
Zimmer, Inc.
Orthopedic
51d