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
Cleared
Jul 01, 1998
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001
Arthrex, Inc.
Orthopedic
90d
Cleared
Jun 25, 1998
CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
Buckman Co., Inc.
Orthopedic
811d
Cleared
Jun 22, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
Depuy, Inc.
Orthopedic
41d
Cleared
May 20, 1998
RCI FIXATION SCREWS
Smith & Nephew, Inc.
Orthopedic
77d
Cleared
May 11, 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
Osteonics Corp.
Orthopedic
35d
Cleared
May 11, 1998
SYNTHES 3.0 MM PC-FIX SYSTEM
Synthes (Usa)
Orthopedic
25d
Cleared
Apr 29, 1998
HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS
Howmedica Corp.
Orthopedic
90d
Cleared
Apr 29, 1998
INNOVASIVE DEVICES MENISCAL SCREW
Innovasive Devices, Inc.
Orthopedic
68d
Cleared
Apr 03, 1998
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
Depuy, Inc.
Orthopedic
58d
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