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).

205
Total
205
Cleared
113d
Avg days
1977
Since
205 devices
145–168 of 205
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 Aug 07, 1987
PIN, HIP, KNOWLES
K872842
Military Engineering, Inc.
Orthopedic · 18d
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
Cleared Sep 22, 1977
PIN RETRACTORS
K771418
Stryker Corp.
Orthopedic · 52d