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.

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
817–840 of 1070
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
Cleared Jul 01, 1998
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001
K981187
Arthrex, Inc.
Orthopedic · 90d
Cleared Jun 25, 1998
CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
K961320
Buckman Co., Inc.
Orthopedic · 811d
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
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K981259
Osteonics Corp.
Orthopedic · 35d
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 29, 1998
INNOVASIVE DEVICES MENISCAL SCREW
K980681
Innovasive Devices, Inc.
Orthopedic · 68d
Cleared Apr 03, 1998
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
K980440
Depuy, Inc.
Orthopedic · 58d