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., Wrightmedicaltechnologyinc and Synthes (Usa).

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
841–864 of 1070
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
Cleared Aug 05, 1997
STRYKER WEDGE INTERFERENCE SCREW SYSTEM
K972233
Stryker Endoscopy
Orthopedic · 50d
Cleared Jul 30, 1997
OSTEO CANNULATED SCREW SYSTEM
K971800
Osteonics Corp.
Orthopedic · 76d
Cleared Jul 09, 1997
34MM SCARF THREAD-HEAD(TM) SCREW
K971068
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
TWIST-OFF (TM) SCREW
K971069
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
SCARF THREAD-HEAD (TM) HEAD SCREW
K971070
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
OSTEO COMPRESSION HIP SCREW SYSTEM
K971654
Osteonics Corp.
Orthopedic · 64d
Cleared Jun 27, 1997
OSTEO SMALL AND MINI BONE SCREWS
K971778
Osteonics Corp.
Orthopedic · 44d
Cleared Jun 09, 1997
DEPUY LOW PROFILE BONE SCREW
K970929
Depuy, Inc.
Orthopedic · 88d
Cleared Apr 30, 1997
TITANIUM ALLOY BONE SCREWS
K970549
Aesculap, Inc.
Orthopedic · 77d