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.
1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
Cleared
Oct 16, 1998
ARTHROTEK INTERFERENCE SCREW
Biomet, Inc.
Orthopedic
88d
Cleared
Jul 29, 1998
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM
Synthes (Usa)
Orthopedic
35d
Cleared
Jul 01, 1998
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001
Arthrex, Inc.
Orthopedic
90d
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
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 03, 1998
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
Depuy, Inc.
Orthopedic
58d
Cleared
Oct 01, 1997
DEPUY DUPONT ABSORBABLE SET SCREW
Depuy, Inc.
Orthopedic
90d
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
Cleared
Apr 03, 1997
BIOMET BONE SCREW
Biomet, Inc.
Orthopedic
112d
Cleared
Feb 27, 1997
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
Smith & Nephew, Inc.
Orthopedic
70d
Cleared
Nov 18, 1996
HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)
Depuy, Inc.
Orthopedic
336d
Cleared
Nov 14, 1996
DEPUY MOTECH PEAK FIXATION SYSTEM
Depuy, Inc.
Orthopedic
80d
Cleared
Nov 08, 1996
SYNTHES STERILE 4.5 MM CANNULATED SCREWS
Synthes (Usa)
Orthopedic
86d
Cleared
Nov 08, 1996
SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS
Synthes (Usa)
Orthopedic
85d
Cleared
Oct 10, 1996
ALTA FULLY THREADED CROSS-LOCKING SCREWS
Howmedica Corp.
Orthopedic
42d
Cleared
Oct 01, 1996
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
Synthes (Usa)
Orthopedic
74d
Cleared
Aug 07, 1996
SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
Synthes (Usa)
Orthopedic
117d
Cleared
Aug 05, 1996
SYNTHES 7.0/7.3 MM CANNULATED SCREWS
Synthes (Usa)
Orthopedic
74d
Cleared
Jun 19, 1996
DEPUY ADVANTAGE FIXATION SCREW SYSTEM
Depuy, Inc.
Orthopedic
82d
Cleared
Jun 06, 1996
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
Depuy, Inc.
Orthopedic
118d
Cleared
Mar 04, 1996
CANNULATED PLUS HIP SCREW (STERILE)
Wrightmedicaltechnologyinc
Orthopedic
69d