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
Cleared
Mar 27, 1998
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW
Bionx Implants, Inc.
Orthopedic
232d
Cleared
Mar 18, 1998
AUTO-DRIVE BONE SCREW
Osteomed Corp.
Orthopedic
86d
Cleared
Mar 12, 1998
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
Biodynamic Technologies, Inc.
Orthopedic
83d
Cleared
Mar 03, 1998
MENISCAL REPAIR DEVICE
Linvatec Corp.
Orthopedic
90d
Cleared
Feb 27, 1998
BIOSCREW ABSORBABLE INTERFERENCE SREW
Linvatec Corp.
Orthopedic
148d
Cleared
Jan 23, 1998
ULTIMATE COMPRESSION SCREW SYSTEM
Orthopedic Designs, Inc.
Orthopedic
186d
Cleared
Jan 16, 1998
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
Vilex, Inc.
Orthopedic
135d
Cleared
Jan 05, 1998
DRG LARGE SCREW SYSTEM
Dolphin Medical Technologies, Inc.
Orthopedic
90d
Cleared
Nov 20, 1997
ORTHOPEDIC SCREW SYSTEM
Ferguson Medical
Orthopedic
161d
Cleared
Nov 10, 1997
THE CORIFIX LIGAMENT ANCHOR
Corin USA
Orthopedic
89d
Cleared
Nov 07, 1997
SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II
Spinal Concepts, Inc.
Orthopedic
46d
Cleared
Oct 01, 1997
LEIBINGER SELF-DRILLING SCREW
Howmedica Leibinger, Inc.
Orthopedic
203d
Cleared
Oct 01, 1997
DEPUY DUPONT ABSORBABLE SET SCREW
Depuy, Inc.
Orthopedic
90d
Cleared
Sep 19, 1997
ACUFEX SCREW CANNULA
Smith & Nephew Endoscopy, Inc.
Orthopedic
67d
Cleared
Aug 29, 1997
BTI CORTICAL BONE SCREWS
Biodynamic Technologies, Inc.
Orthopedic
64d
Cleared
Aug 05, 1997
STRYKER WEDGE INTERFERENCE SCREW SYSTEM
Stryker Endoscopy
Orthopedic
50d
Cleared
Jul 30, 1997
OSTEO CANNULATED SCREW SYSTEM
Osteonics Corp.
Orthopedic
76d
Cleared
Jul 09, 1997
34MM SCARF THREAD-HEAD(TM) SCREW
Landos, Inc.
Orthopedic
107d
Cleared
Jul 09, 1997
TWIST-OFF (TM) SCREW
Landos, Inc.
Orthopedic
107d
Cleared
Jul 09, 1997
SCARF THREAD-HEAD (TM) HEAD SCREW
Landos, Inc.
Orthopedic
107d
Cleared
Jul 09, 1997
OSTEO COMPRESSION HIP SCREW SYSTEM
Osteonics Corp.
Orthopedic
64d
Cleared
Jun 27, 1997
OSTEO SMALL AND MINI BONE SCREWS
Osteonics Corp.
Orthopedic
44d
Cleared
Jun 09, 1997
DEPUY LOW PROFILE BONE SCREW
Depuy, Inc.
Orthopedic
88d
Cleared
Apr 30, 1997
TITANIUM ALLOY BONE SCREWS
Aesculap, Inc.
Orthopedic
77d