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 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 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 Nov 20, 1997
SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION
K973240
Synthes (Usa)
Orthopedic · 84d
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 Mar 27, 1996
STERILE KIRSCHNER WIRES AND STEINMANN PINS
K960385
Depuy, Inc.
Orthopedic · 61d
Cleared Oct 31, 1995
LACTOSORB BONE PIN
K953194
Biomet, Inc.
Orthopedic · 113d
Cleared Oct 26, 1995
SPETZLER PIN
K954001
Howmedica Corp.
Orthopedic · 62d
Cleared Apr 14, 1995
SPETZLER PIN
K945639
Howmedica Corp.
Orthopedic · 149d