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).

204
Total
204
Cleared
114d
Avg days
1977
Since
204 devices
49–72 of 204
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 Jan 19, 2005
PINN-ACL CROSSPIN
K043106
Linvatec Corp.
Orthopedic · 71d
Cleared Jul 30, 2004
HUMERAL STAPLE
K041355
Smith & Nephew, Inc.
Orthopedic · 71d
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 26, 2002
2MM PEDIATRIC FLEX NAIL
K022531
Biomet, Inc.
Orthopedic · 26d
Cleared Jul 31, 2001
RESORBABLE BONE PINS
K011522
Biomet, Inc.
Orthopedic · 75d
Cleared Apr 09, 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527
Synthes (Usa)
Orthopedic · 144d
Cleared Aug 04, 2000
ARTHREX CHONDRAL DART, MODEL AR-4005B-18
K991971
Arthrex, Inc.
Orthopedic · 420d
Cleared Mar 23, 1999
LACTOSORB BONE PIN
K990291
Biomet, Inc.
Orthopedic · 53d
Cleared Aug 11, 1998
RETROGRADE PEDIATRIC NAIL
K980854
Encore Orthopedics, Inc.
Orthopedic · 159d
Cleared Nov 20, 1997
SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION
K973240
Synthes (Usa)
Orthopedic · 84d
Cleared Aug 11, 1997
OSTEO KIRSCHNER WIRES
K971962
Osteonics Corp.
Orthopedic · 75d
Cleared Jul 18, 1997
SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM
K971783
Synthes (Usa)
Orthopedic · 65d
Cleared May 09, 1997
SYNTHES (U.S.A.) POLYPIN
K961608
Synthes (Usa)
Orthopedic · 379d
Cleared Apr 02, 1997
SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM
K970733
Synthes (Usa)
Orthopedic · 33d
Cleared Mar 25, 1997
FIXATION PIN OR ROD
K970036
United States Surgical, A Division of Tyco Healthc
Orthopedic · 81d
Cleared Dec 09, 1996
ACUMED TENSION BAND PIN
K964500
Acu Med, Inc.
Orthopedic · 31d