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).

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
769–792 of 1064
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
Cleared Apr 03, 1997
BIOMET BONE SCREW
K964970
Biomet, Inc.
Orthopedic · 112d
Cleared Feb 27, 1997
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
K965073
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Jan 22, 1997
LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
K963739
Howmedica Leibinger, Inc.
Orthopedic · 127d
Cleared Jan 22, 1997
NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW
K963937
Northwest Precision Technologies
Orthopedic · 113d
Cleared Nov 18, 1996
HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)
K955733
Depuy, Inc.
Orthopedic · 336d
Cleared Nov 14, 1996
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960652
Linvatec Corp.
Orthopedic · 273d
Cleared Nov 14, 1996
DEPUY MOTECH PEAK FIXATION SYSTEM
K963350
Depuy, Inc.
Orthopedic · 80d
Cleared Nov 13, 1996
EZ-FIX CANNULATED SCREW SYSTEM
K962706
Biodynamic Technologies, Inc.
Orthopedic · 124d
Cleared Nov 08, 1996
SYNTHES STERILE 4.5 MM CANNULATED SCREWS
K963172
Synthes (Usa)
Orthopedic · 86d
Cleared Nov 08, 1996
SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS
K963192
Synthes (Usa)
Orthopedic · 85d
Cleared Nov 04, 1996
EZ-FIX SMALL CANNULATED SCREW SYSTEM
K962987
Biodynamic Technologies, Inc.
Orthopedic · 95d
Cleared Oct 10, 1996
EXTREMITY BONE SCREW
K963118
Acu Med, Inc.
Orthopedic · 59d
Cleared Oct 10, 1996
ALTA FULLY THREADED CROSS-LOCKING SCREWS
K963398
Howmedica Corp.
Orthopedic · 42d
Cleared Oct 03, 1996
TWIST-OFF SCREW
K962233
Landos, Inc.
Orthopedic · 114d
Cleared Oct 01, 1996
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
K962823
Synthes (Usa)
Orthopedic · 74d