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
97–120 of 205
Cleared Oct 30, 2002
NEWDEAL K WIRE
K022599
New Deal, S.A.
Orthopedic · 86d
Cleared Aug 26, 2002
2MM PEDIATRIC FLEX NAIL
K022531
Biomet, Inc.
Orthopedic · 26d
Cleared May 01, 2002
FIXATION (STEINMANN) PINS
K013888
Miltex, Inc.
Orthopedic · 159d
Cleared Mar 29, 2002
RESORBABLE LACTOSORB-L ACL CROSSPIN
K014305
Arthrotek, Inc.
Orthopedic · 88d
Cleared Feb 06, 2002
RIDIDFIX 2.7MM BTB CROSS PIN KIT
K013781
Mitek Products
Orthopedic · 84d
Cleared Jul 31, 2001
RESORBABLE BONE PINS
K011522
Biomet, Inc.
Orthopedic · 75d
Cleared Jun 13, 2001
PLLA PIN
K010983
Bionx Implants, Inc.
Orthopedic · 72d
Cleared Apr 09, 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527
Synthes (Usa)
Orthopedic · 144d
Cleared Feb 20, 2001
PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260
K003659
Bionx Implants, Inc.
Orthopedic · 84d
Cleared Aug 04, 2000
ARTHREX CHONDRAL DART, MODEL AR-4005B-18
K991971
Arthrex, Inc.
Orthopedic · 420d
Cleared Mar 01, 2000
PHALANGEAL FIXATION SYSTEM
K994232
Medcanica, Inc.
Orthopedic · 76d
Cleared Jun 23, 1999
METACARPAL FIXATION SYSTEM
K991064
Medcanica, Inc.
Orthopedic · 84d
Cleared Mar 23, 1999
LACTOSORB BONE PIN
K990291
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
K983121
Syntec Scientific Corp.
Orthopedic · 27d
Cleared Sep 25, 1998
THE BONE TIE
K982719
Surgicraft , Ltd.
Orthopedic · 52d
Cleared Aug 11, 1998
RETROGRADE PEDIATRIC NAIL
K980854
Encore Orthopedics, Inc.
Orthopedic · 159d
Cleared Apr 16, 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
K974341
Mitek Products
Orthopedic · 149d
Cleared Mar 05, 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
K974291
Mitek Products
Orthopedic · 111d
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 Jun 24, 1997
ORTHOTEC K-CAP SYSTEM
K971453
Orthotech
Orthopedic · 64d
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