HWC · Class II · 21 CFR 888.3040

FDA Product Code HWC: Screw, Fixation, Bone

FDA product code HWC covers bone fixation screws.

These implants are used to stabilize fractures, osteotomies, and bone grafts by compressing bone fragments together or anchoring plates and other fixation constructs. They are available in cortical, cancellous, and cannulated configurations for different anatomical sites and indications.

HWC devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Arthrex, Inc., Synthes (Usa) and Wrightmedicaltechnologyinc.

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
745–768 of 1064
Cleared Jul 01, 1998
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001
K981187
Arthrex, Inc.
Orthopedic · 90d
Cleared Jun 25, 1998
CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
K961320
Buckman Co., Inc.
Orthopedic · 811d
Cleared Jun 22, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K981670
Depuy, Inc.
Orthopedic · 41d
Cleared May 20, 1998
RCI FIXATION SCREWS
K980841
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared May 11, 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K981259
Osteonics Corp.
Orthopedic · 35d
Cleared May 11, 1998
SYNTHES 3.0 MM PC-FIX SYSTEM
K981372
Synthes (Usa)
Orthopedic · 25d
Cleared Apr 29, 1998
HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS
K980364
Howmedica Corp.
Orthopedic · 90d
Cleared Apr 29, 1998
INNOVASIVE DEVICES MENISCAL SCREW
K980681
Innovasive Devices, Inc.
Orthopedic · 68d
Cleared Apr 03, 1998
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
K980440
Depuy, Inc.
Orthopedic · 58d
Cleared Mar 27, 1998
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW
K972919
Bionx Implants, Inc.
Orthopedic · 232d
Cleared Mar 18, 1998
AUTO-DRIVE BONE SCREW
K974785
Osteomed Corp.
Orthopedic · 86d
Cleared Mar 12, 1998
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
K974756
Biodynamic Technologies, Inc.
Orthopedic · 83d
Cleared Mar 03, 1998
MENISCAL REPAIR DEVICE
K974538
Linvatec Corp.
Orthopedic · 90d
Cleared Feb 27, 1998
BIOSCREW ABSORBABLE INTERFERENCE SREW
K973758
Linvatec Corp.
Orthopedic · 148d
Cleared Jan 23, 1998
ULTIMATE COMPRESSION SCREW SYSTEM
K972722
Orthopedic Designs, Inc.
Orthopedic · 186d
Cleared Jan 16, 1998
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
K973309
Vilex, Inc.
Orthopedic · 135d
Cleared Jan 05, 1998
DRG LARGE SCREW SYSTEM
K973810
Dolphin Medical Technologies, Inc.
Orthopedic · 90d
Cleared Nov 20, 1997
ORTHOPEDIC SCREW SYSTEM
K972217
Ferguson Medical
Orthopedic · 161d
Cleared Nov 10, 1997
THE CORIFIX LIGAMENT ANCHOR
K973005
Corin USA
Orthopedic · 89d
Cleared Nov 07, 1997
SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II
K973586
Spinal Concepts, Inc.
Orthopedic · 46d
Cleared Oct 01, 1997
LEIBINGER SELF-DRILLING SCREW
K970912
Howmedica Leibinger, Inc.
Orthopedic · 203d
Cleared Oct 01, 1997
DEPUY DUPONT ABSORBABLE SET SCREW
K972494
Depuy, Inc.
Orthopedic · 90d
Cleared Sep 19, 1997
ACUFEX SCREW CANNULA
K972599
Smith & Nephew Endoscopy, Inc.
Orthopedic · 67d
Cleared Aug 29, 1997
BTI CORTICAL BONE SCREWS
K972403
Biodynamic Technologies, Inc.
Orthopedic · 64d