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