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.

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
265–288 of 1064
Cleared Jan 26, 2016
Tenodesis screw system
K151701
Normed Medizin-Technik GmbH
Orthopedic · 216d
Cleared Jan 19, 2016
Epic Extremity Cannulated Screw System
K153333
Epic Extremity, LLC
Orthopedic · 61d
Cleared Jan 14, 2016
Tiger Cannulated Screw System
K153338
Trilliant Surgical, Ltd.
Orthopedic · 56d
Cleared Dec 28, 2015
Asnis JFX System
K153154
Stryker Trauma AG
Orthopedic · 56d
Cleared Dec 21, 2015
Monster BITE Screw System
K153378
Paragon 28
Orthopedic · 28d
Cleared Nov 25, 2015
Tyber Medical MST Trauma Screw
K153180
Tyber Medical, LLC
Orthopedic · 22d
Cleared Nov 25, 2015
SELF- COMPRESSIVE SCREW
K153182
Neosteo
Orthopedic · 22d
Cleared Nov 24, 2015
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
K152841
Zimmer, Inc.
Orthopedic · 56d
Cleared Nov 10, 2015
EzFuze Implant System
K150211
Vilex IN Tennessee, Inc.
Orthopedic · 284d
Cleared Oct 29, 2015
Integra DigiFuse Cannulated Intramedullary Fusion System
K152527
Ascension Orthopedics
Orthopedic · 56d
Cleared Oct 15, 2015
HammerFiX Device
K152710
Extremity Medical, LLC
Orthopedic · 24d
Cleared Oct 13, 2015
PHIN-FX Cannulated Lag Screw System
K150693
Ascent Medical, LLC
Orthopedic · 209d
Cleared Sep 23, 2015
CrossRoads Screw System
K152072
Crossroads Extremity Systems, LLC
Orthopedic · 58d
Cleared Sep 04, 2015
CrossTIE Intraosseous Fixation System
K151270
Crossroads Extremity Systems, LLC
Orthopedic · 114d
Cleared Sep 04, 2015
PRO-TOE Hammertoe Fixation System
K151838
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Aug 07, 2015
Synchro-Medical TIGER TRACK Screw System
K151241
Synchro Medical
Orthopedic · 88d
Cleared Aug 04, 2015
ForeFoot STP System
K150871
Tornier, Inc.
Orthopedic · 125d
Cleared Jul 24, 2015
N-Force Fixation System
K151146
Innovision, Inc.
Orthopedic · 86d
Cleared Jul 15, 2015
OsteoMed Cannulated Screw System
K151021
Osteomed Corp.
Orthopedic · 90d
Cleared Jul 15, 2015
Monster Screw System
K151418
Paragon 28
Orthopedic · 48d
Cleared Jun 23, 2015
SMV Scientific Bone Screws
K150981
Smv Scientific
Orthopedic · 70d
Cleared Jun 12, 2015
Sonoma Cancellous Bone Screw and Washer
K150376
Sonoma Orthopedics Products, Inc.
Orthopedic · 119d
Cleared Jun 04, 2015
ToeTac Hammertoe Fixation System
K150443
Restore Surgical, LLC Dba Instratek
Orthopedic · 104d
Cleared May 26, 2015
Biomet Microfixation RibFix Blu Thoracic Fixation System
K151173
Biomet Microfixation
Orthopedic · 25d