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