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., Synthes (Usa) and Wrightmedicaltechnologyinc.

1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
337–360 of 1059
Cleared Oct 16, 1998
ARTHROTEK INTERFERENCE SCREW
K982497
Biomet, Inc.
Orthopedic · 88d
Cleared Jul 29, 1998
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM
K982222
Synthes (Usa)
Orthopedic · 35d
Cleared Jul 01, 1998
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001
K981187
Arthrex, Inc.
Orthopedic · 90d
Cleared Jun 22, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K981670
Depuy, Inc.
Orthopedic · 41d
Cleared May 20, 1998
RCI FIXATION SCREWS
K980841
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared May 11, 1998
SYNTHES 3.0 MM PC-FIX SYSTEM
K981372
Synthes (Usa)
Orthopedic · 25d
Cleared Apr 29, 1998
HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS
K980364
Howmedica Corp.
Orthopedic · 90d
Cleared Apr 03, 1998
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
K980440
Depuy, Inc.
Orthopedic · 58d
Cleared Oct 01, 1997
DEPUY DUPONT ABSORBABLE SET SCREW
K972494
Depuy, Inc.
Orthopedic · 90d
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 Nov 18, 1996
HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)
K955733
Depuy, Inc.
Orthopedic · 336d
Cleared Nov 14, 1996
DEPUY MOTECH PEAK FIXATION SYSTEM
K963350
Depuy, Inc.
Orthopedic · 80d
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 Oct 10, 1996
ALTA FULLY THREADED CROSS-LOCKING SCREWS
K963398
Howmedica Corp.
Orthopedic · 42d
Cleared Oct 01, 1996
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
K962823
Synthes (Usa)
Orthopedic · 74d
Cleared Aug 07, 1996
SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
K961413
Synthes (Usa)
Orthopedic · 117d
Cleared Aug 05, 1996
SYNTHES 7.0/7.3 MM CANNULATED SCREWS
K962011
Synthes (Usa)
Orthopedic · 74d
Cleared Jun 19, 1996
DEPUY ADVANTAGE FIXATION SCREW SYSTEM
K961234
Depuy, Inc.
Orthopedic · 82d
Cleared Jun 06, 1996
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
K960704
Depuy, Inc.
Orthopedic · 118d
Cleared Mar 04, 1996
CANNULATED PLUS HIP SCREW (STERILE)
K955837
Wrightmedicaltechnologyinc
Orthopedic · 69d