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 Biomet, Inc..

205
Total
205
Cleared
113d
Avg days
1977
Since
205 devices
121–144 of 205
Cleared Mar 25, 1997
FIXATION PIN OR ROD
K970036
United States Surgical, A Division of Tyco Healthc
Orthopedic · 81d
Cleared Mar 13, 1997
BIORIGID NAIL TIBIA
K970013
Aap GmbH and Co. Betriebs KG
Orthopedic · 70d
Cleared Dec 09, 1996
ACUMED TENSION BAND PIN
K964500
Acu Med, Inc.
Orthopedic · 31d
Cleared Nov 25, 1996
BLOCK STOP WIRES
K964087
Ferguson Medical
Orthopedic · 45d
Cleared Oct 30, 1996
RMS K-WIRE
K963367
Rms Div.
Orthopedic · 64d
Cleared Sep 23, 1996
KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
K961522
Synvasive Technology, Inc.
Orthopedic · 154d
Cleared May 17, 1996
NANCY NAIL
K960642
Landos, Inc.
Orthopedic · 93d
Cleared Apr 09, 1996
K-WIRE
K960482
American Medical Specialties, Inc.
Orthopedic · 67d
Cleared Apr 09, 1996
STEINMAN PIN
K960483
American Medical Specialties, Inc.
Orthopedic · 67d
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 Mar 01, 1994
ORTHOPEDIC SMOOTH PIN FIXATION
K932348
Osteomed Corp.
Orthopedic · 291d
Cleared Jul 09, 1993
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766
Acufex Microsurgical, Inc.
Orthopedic · 402d
Cleared Mar 16, 1993
OTI ORTHOPEDIC FASTENER SYSTEM
K925301
Osteo Technology, Inc.
Orthopedic · 146d
Cleared Dec 11, 1990
STEINMAN PIN
K905337
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
RUSH PIN
K905341
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
K-WIRE
K905345
O'Tec Corp.
Orthopedic · 13d
Cleared Jul 30, 1990
K-WIRE
K903264
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
STEINMAN PIN
K903265
Onyx Medical Corp.
Orthopedic · 6d