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
73–96 of 204
Cleared Nov 25, 1996
BLOCK STOP WIRES
K964087
Ferguson Medical
Orthopedic · 45d
Cleared Mar 27, 1996
STERILE KIRSCHNER WIRES AND STEINMANN PINS
K960385
Depuy, Inc.
Orthopedic · 61d
Cleared Feb 15, 1996
HOWMEDICA BIOABSORBABLE PIN
K955806
Howmedica, Inc.
Orthopedic · 55d
Cleared Oct 31, 1995
LACTOSORB BONE PIN
K953194
Biomet, Inc.
Orthopedic · 113d
Cleared Oct 26, 1995
SPETZLER PIN
K954001
Howmedica Corp.
Orthopedic · 62d
Cleared Jul 06, 1995
FIXATION PINS/WIRES
K943856
Acu Med, Inc.
Orthopedic · 332d
Cleared Apr 14, 1995
SPETZLER PIN
K945639
Howmedica Corp.
Orthopedic · 149d
Cleared Jun 28, 1994
ACUFEX SMOOTH AND THREADED PINS
K931836
Acufex Microsurgical, Inc.
Orthopedic · 441d
Cleared Jul 09, 1993
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766
Acufex Microsurgical, Inc.
Orthopedic · 402d
Cleared Jul 30, 1990
K-WIRE
K903264
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
STEINMAN PIN
K903265
Onyx Medical Corp.
Orthopedic · 6d
Cleared Nov 03, 1989
BIOFIX* BIODEGRADABLE FIXATION ROD
K890902
Davis & Geck, Inc.
Orthopedic · 254d
Cleared Sep 13, 1989
ACE BEADED K-WIRES ACE OLIVE WIRES
K895079
Buckman Co., Inc.
Orthopedic · 30d
Cleared Jan 07, 1988
ORTHOMET PIN SYSTEM
K874913
Orthomet, Inc.
Orthopedic · 35d
Cleared Jul 09, 1987
PDS (POLYDIOXANON) ABSORBABLE PIN
K864912
Johnson & Johnson Professionals, Inc.
Orthopedic · 206d
Cleared Oct 20, 1986
STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS
K863734
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 27d
Cleared Sep 03, 1986
CANNULATED LAG SCREWS
K863119
Downs Surgical , Ltd.
Orthopedic · 20d
Cleared Mar 07, 1986
ACE UNILATERAL FIXATOR
K860590
Buckman Co., Inc.
Orthopedic · 16d
Cleared Jun 28, 1985
PINSET, BONE, RUSH 9-1/2 THRU 20-3/4 INCHES LONG
K852560
The Huxley Instrument Corp.
Orthopedic · 11d
Cleared Jun 28, 1985
PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONG
K852561
The Huxley Instrument Corp.
Orthopedic · 11d
Cleared Jun 28, 1985
PIN SET, BONE, RUSH, 4 THRU 10 1/2 INCHES LONG
K852562
The Huxley Instrument Corp.
Orthopedic · 11d
Cleared Jun 28, 1985
PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONG
K852563
The Huxley Instrument Corp.
Orthopedic · 11d
Cleared Feb 10, 1984
FIXATION PINS
K833952
Ethicon, Inc.
Orthopedic · 86d
Cleared May 18, 1983
WIRE & STEINMAN PINS
K831005
Kirschner Medical Corp.
Orthopedic · 49d