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
73–96 of 205
Cleared Oct 11, 2011
APEX KIRSCHNER WIRES AND STEINMANN PINS
K112254
Apex Tools & Orthopedics Co.
Orthopedic · 67d
Cleared Apr 28, 2011
PCL TIGHTROPE
K110123
Arthrex, Inc.
Orthopedic · 100d
Cleared Feb 28, 2011
VERTICOR K-WIRE SYSTEM
K110047
Verticor, Ltd.
Orthopedic · 53d
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 Sep 23, 2009
APTUS K-WIRE SYSTEM
K092038
Medartis AG
Orthopedic · 79d
Cleared Mar 18, 2009
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
K083490
Biopro, Inc.
Orthopedic · 113d
Cleared Oct 17, 2008
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
K082375
OrthoPediatrics Corp.
Orthopedic · 60d
Cleared May 25, 2007
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES
K070561
Teleflex Medical
Orthopedic · 87d
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
Cleared Apr 18, 2005
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L
K043339
Xtremi-T, LLC
Orthopedic · 136d
Cleared Mar 07, 2005
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN
K050275
Inion , Ltd.
Orthopedic · 28d
Cleared Jan 19, 2005
PINN-ACL CROSSPIN
K043106
Linvatec Corp.
Orthopedic · 71d
Cleared Jul 30, 2004
MODIFICATION TO SMALL BONE FIXATION SYSTEM
K041157
Hand Innovations, Inc.
Orthopedic · 88d
Cleared Jul 30, 2004
HUMERAL STAPLE
K041355
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jun 10, 2004
MODIFICATION TO SMARTPIN
K041288
Linvatec Biomaterials, Inc.
Orthopedic · 28d
Cleared May 25, 2004
ARTHROTEK LACTONAIL
K040500
Arthrotek, Inc.
Orthopedic · 89d
Cleared Feb 20, 2004
HANSSON PIN SYSTEM
K033968
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Oct 06, 2003
ACE NANCY NAIL
K032687
DePuy Orthopaedics, Inc.
Orthopedic · 38d
Cleared Aug 28, 2003
INION OTPS BIODEGRADABLE PIN
K031712
Inion , Ltd.
Orthopedic · 87d
Cleared Nov 01, 2002
K-FIX
K022597
New Deal, S.A.
Orthopedic · 88d