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
Jul 30, 2004
HUMERAL STAPLE
Smith & Nephew, Inc.
Orthopedic
71d
Cleared
Feb 20, 2004
HANSSON PIN SYSTEM
Howmedica Osteonics Corp.
Orthopedic
60d
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
Nov 20, 1997
SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION
Synthes (Usa)
Orthopedic
84d
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
Mar 27, 1996
STERILE KIRSCHNER WIRES AND STEINMANN PINS
Depuy, Inc.
Orthopedic
61d
Cleared
Oct 31, 1995
LACTOSORB BONE PIN
Biomet, Inc.
Orthopedic
113d
Cleared
Oct 26, 1995
SPETZLER PIN
Howmedica Corp.
Orthopedic
62d
Cleared
Apr 14, 1995
SPETZLER PIN
Howmedica Corp.
Orthopedic
149d