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
Oct 11, 2011
APEX KIRSCHNER WIRES AND STEINMANN PINS
Apex Tools & Orthopedics Co.
Orthopedic
67d
Cleared
Apr 28, 2011
PCL TIGHTROPE
Arthrex, Inc.
Orthopedic
100d
Cleared
Feb 28, 2011
VERTICOR K-WIRE SYSTEM
Verticor, Ltd.
Orthopedic
53d
Cleared
Dec 28, 2010
ACL TIGHTROPE DOUBLE BUNDLE
Arthrex, Inc.
Orthopedic
180d
Cleared
Jun 23, 2010
ACL TIGHTROPE
Arthrex, Inc.
Orthopedic
107d
Cleared
Apr 02, 2010
STRYKER SONICPIN SYSTEM
Howmedica Osteonics Corp.
Orthopedic
275d
Cleared
Sep 23, 2009
APTUS K-WIRE SYSTEM
Medartis AG
Orthopedic
79d
Cleared
Mar 18, 2009
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
Biopro, Inc.
Orthopedic
113d
Cleared
Oct 17, 2008
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
OrthoPediatrics Corp.
Orthopedic
60d
Cleared
May 25, 2007
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES
Teleflex Medical
Orthopedic
87d
Cleared
Mar 06, 2007
ARTHREX CROSSPIN, MODEL AR-1964P
Arthrex, Inc.
Orthopedic
81d
Cleared
Nov 03, 2005
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT
Arthrex, Inc.
Orthopedic
34d
Cleared
May 27, 2005
ARTHREX BIO-PIN
Arthrex, Inc.
Orthopedic
113d
Cleared
Apr 18, 2005
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L
Xtremi-T, LLC
Orthopedic
136d
Cleared
Mar 07, 2005
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN
Inion , Ltd.
Orthopedic
28d
Cleared
Jan 19, 2005
PINN-ACL CROSSPIN
Linvatec Corp.
Orthopedic
71d
Cleared
Jul 30, 2004
MODIFICATION TO SMALL BONE FIXATION SYSTEM
Hand Innovations, Inc.
Orthopedic
88d
Cleared
Jul 30, 2004
HUMERAL STAPLE
Smith & Nephew, Inc.
Orthopedic
71d
Cleared
Jun 10, 2004
MODIFICATION TO SMARTPIN
Linvatec Biomaterials, Inc.
Orthopedic
28d
Cleared
May 25, 2004
ARTHROTEK LACTONAIL
Arthrotek, Inc.
Orthopedic
89d
Cleared
Feb 20, 2004
HANSSON PIN SYSTEM
Howmedica Osteonics Corp.
Orthopedic
60d
Cleared
Oct 06, 2003
ACE NANCY NAIL
DePuy Orthopaedics, Inc.
Orthopedic
38d
Cleared
Aug 28, 2003
INION OTPS BIODEGRADABLE PIN
Inion , Ltd.
Orthopedic
87d
Cleared
Nov 01, 2002
K-FIX
New Deal, S.A.
Orthopedic
88d