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
Cleared
Mar 25, 1997
FIXATION PIN OR ROD
United States Surgical, A Division of Tyco Healthc
Orthopedic
81d
Cleared
Mar 13, 1997
BIORIGID NAIL TIBIA
Aap GmbH and Co. Betriebs KG
Orthopedic
70d
Cleared
Dec 09, 1996
ACUMED TENSION BAND PIN
Acu Med, Inc.
Orthopedic
31d
Cleared
Nov 25, 1996
BLOCK STOP WIRES
Ferguson Medical
Orthopedic
45d
Cleared
Oct 30, 1996
RMS K-WIRE
Rms Div.
Orthopedic
64d
Cleared
Sep 23, 1996
KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
Synvasive Technology, Inc.
Orthopedic
154d
Cleared
May 17, 1996
NANCY NAIL
Landos, Inc.
Orthopedic
93d
Cleared
Apr 09, 1996
K-WIRE
American Medical Specialties, Inc.
Orthopedic
67d
Cleared
Apr 09, 1996
STEINMAN PIN
American Medical Specialties, Inc.
Orthopedic
67d
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
Mar 01, 1994
ORTHOPEDIC SMOOTH PIN FIXATION
Osteomed Corp.
Orthopedic
291d
Cleared
Jul 09, 1993
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
Acufex Microsurgical, Inc.
Orthopedic
402d
Cleared
Mar 16, 1993
OTI ORTHOPEDIC FASTENER SYSTEM
Osteo Technology, Inc.
Orthopedic
146d
Cleared
Dec 11, 1990
STEINMAN PIN
O'Tec Corp.
Orthopedic
13d
Cleared
Dec 11, 1990
RUSH PIN
O'Tec Corp.
Orthopedic
13d
Cleared
Dec 11, 1990
K-WIRE
O'Tec Corp.
Orthopedic
13d
Cleared
Jul 30, 1990
K-WIRE
Onyx Medical Corp.
Orthopedic
6d
Cleared
Jul 30, 1990
STEINMAN PIN
Onyx Medical Corp.
Orthopedic
6d