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
721–744 of 1064
Cleared Jul 14, 1999
SPIN SNAP-OFF SCREW
K991477
New Deal, S.A.
Orthopedic · 77d
Cleared Jul 01, 1999
BIO-INTERFERENCE SCREW
K990454
Innovasive Devices, Inc.
Orthopedic · 139d
Cleared Jun 01, 1999
BONE SCREWS
K990351
Bregma International Trading Company , Ltd.
Orthopedic · 116d
Cleared May 14, 1999
BONE MULCH SCREW SYSTEM
K991298
Biomet, Inc.
Orthopedic · 29d
Cleared Apr 29, 1999
BOLD SCREW
K990622
New Deal, S.A.
Orthopedic · 63d
Cleared Apr 29, 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
K990776
Aap Implantate AG
Orthopedic · 51d
Cleared Apr 29, 1999
STAYFUSE
K990804
Pioneer Surgical Technology
Orthopedic · 50d
Cleared Apr 26, 1999
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW
K991151
Vilex, Inc.
Orthopedic · 20d
Cleared Apr 26, 1999
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24
K991197
Vilex, Inc.
Orthopedic · 19d
Cleared Mar 17, 1999
ULTIMAX CORTICAL BONE SCREWS
K990513
Biodynamic Technologies, Inc.
Orthopedic · 27d
Cleared Mar 15, 1999
DRG MEDIUM SCREW SYSTEM
K990019
Dolphin Medical Technologies, Inc.
Orthopedic · 70d
Cleared Feb 03, 1999
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
K984209
Biomet, Inc.
Orthopedic · 71d
Cleared Jan 28, 1999
SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
K983592
Sulzer Orthopedics, Inc.
Orthopedic · 107d
Cleared Jan 28, 1999
BIOABSORBABLE INTERFERENCE SCREWS
K984320
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Jan 20, 1999
ODI ULTIMATE COMPRESSION HIP SCREW
K984331
Orthopedic Designs, Inc.
Orthopedic · 48d
Cleared Dec 22, 1998
PHUSIS ABSORBABLE INTERFERENCE SCREW
K970829
Tornier
Orthopedic · 656d
Cleared Dec 16, 1998
SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420
K983495
Syntec Scientific Corp.
Orthopedic · 72d
Cleared Dec 07, 1998
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K983508
Osteonics Corp.
Orthopedic · 61d
Cleared Dec 03, 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K983165
Osteonics Corp.
Orthopedic · 84d
Cleared Nov 23, 1998
OSTEO 5.0MM CANNULATED SCREW SYSTEM
K983006
Stryker Osteonics
Orthopedic · 87d
Cleared Oct 28, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K982662
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Oct 16, 1998
ARTHROTEK INTERFERENCE SCREW
K982497
Biomet, Inc.
Orthopedic · 88d
Cleared Sep 08, 1998
ENDO ABSORBABLE INTERFERENCE SCREW
K980457
Endo Surgical Concepts, Inc.
Orthopedic · 215d
Cleared Jul 29, 1998
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM
K982222
Synthes (Usa)
Orthopedic · 35d