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 30, 2002
NEWDEAL K WIRE
New Deal, S.A.
Orthopedic
86d
Cleared
Aug 26, 2002
2MM PEDIATRIC FLEX NAIL
Biomet, Inc.
Orthopedic
26d
Cleared
May 01, 2002
FIXATION (STEINMANN) PINS
Miltex, Inc.
Orthopedic
159d
Cleared
Mar 29, 2002
RESORBABLE LACTOSORB-L ACL CROSSPIN
Arthrotek, Inc.
Orthopedic
88d
Cleared
Feb 06, 2002
RIDIDFIX 2.7MM BTB CROSS PIN KIT
Mitek Products
Orthopedic
84d
Cleared
Jul 31, 2001
RESORBABLE BONE PINS
Biomet, Inc.
Orthopedic
75d
Cleared
Jun 13, 2001
PLLA PIN
Bionx Implants, Inc.
Orthopedic
72d
Cleared
Apr 09, 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
Synthes (Usa)
Orthopedic
144d
Cleared
Feb 20, 2001
PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260
Bionx Implants, Inc.
Orthopedic
84d
Cleared
Aug 04, 2000
ARTHREX CHONDRAL DART, MODEL AR-4005B-18
Arthrex, Inc.
Orthopedic
420d
Cleared
Mar 01, 2000
PHALANGEAL FIXATION SYSTEM
Medcanica, Inc.
Orthopedic
76d
Cleared
Jun 23, 1999
METACARPAL FIXATION SYSTEM
Medcanica, Inc.
Orthopedic
84d
Cleared
Mar 23, 1999
LACTOSORB BONE PIN
Biomet, Inc.
Orthopedic
53d
Cleared
Oct 05, 1998
NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220
Syntec Scientific Corp.
Orthopedic
27d
Cleared
Sep 25, 1998
THE BONE TIE
Surgicraft , Ltd.
Orthopedic
52d
Cleared
Aug 11, 1998
RETROGRADE PEDIATRIC NAIL
Encore Orthopedics, Inc.
Orthopedic
159d
Cleared
Apr 16, 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
Mitek Products
Orthopedic
149d
Cleared
Mar 05, 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
Mitek Products
Orthopedic
111d
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
Jun 24, 1997
ORTHOTEC K-CAP SYSTEM
Orthotech
Orthopedic
64d
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