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