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
Cleared
Mar 09, 2016
Biomet Variable Pitch Compression Screw System
Biomet, Inc.
Orthopedic
57d
Cleared
Mar 02, 2016
RECON system - Compression Screws
Normed Medizin-Technik GmbH
Orthopedic
252d
Cleared
Feb 26, 2016
Tyber Medical Trauma Screw
Tyber Medical, LLC
Orthopedic
73d
Cleared
Feb 25, 2016
SIGN Compression Screw System
Sign Fracture Care International
Orthopedic
57d
Cleared
Feb 12, 2016
MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws
Merete Medical GmbH
Orthopedic
191d
Cleared
Feb 05, 2016
MINIARS SCREWS
Overmed Srl.
Orthopedic
414d
Cleared
Jan 26, 2016
Tenodesis screw system
Normed Medizin-Technik GmbH
Orthopedic
216d
Cleared
Jan 19, 2016
Epic Extremity Cannulated Screw System
Epic Extremity, LLC
Orthopedic
61d
Cleared
Jan 14, 2016
Tiger Cannulated Screw System
Trilliant Surgical, Ltd.
Orthopedic
56d
Cleared
Dec 28, 2015
Asnis JFX System
Stryker Trauma AG
Orthopedic
56d
Cleared
Dec 21, 2015
Monster BITE Screw System
Paragon 28
Orthopedic
28d
Cleared
Nov 25, 2015
Tyber Medical MST Trauma Screw
Tyber Medical, LLC
Orthopedic
22d
Cleared
Nov 25, 2015
SELF- COMPRESSIVE SCREW
Neosteo
Orthopedic
22d
Cleared
Nov 24, 2015
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
Zimmer, Inc.
Orthopedic
56d
Cleared
Nov 10, 2015
EzFuze Implant System
Vilex IN Tennessee, Inc.
Orthopedic
284d
Cleared
Oct 29, 2015
Integra DigiFuse Cannulated Intramedullary Fusion System
Ascension Orthopedics
Orthopedic
56d
Cleared
Oct 15, 2015
HammerFiX Device
Extremity Medical, LLC
Orthopedic
24d
Cleared
Oct 13, 2015
PHIN-FX Cannulated Lag Screw System
Ascent Medical, LLC
Orthopedic
209d
Cleared
Sep 23, 2015
CrossRoads Screw System
Crossroads Extremity Systems, LLC
Orthopedic
58d
Cleared
Sep 04, 2015
CrossTIE Intraosseous Fixation System
Crossroads Extremity Systems, LLC
Orthopedic
114d
Cleared
Sep 04, 2015
PRO-TOE Hammertoe Fixation System
Wrightmedicaltechnologyinc
Orthopedic
60d
Cleared
Aug 07, 2015
Synchro-Medical TIGER TRACK Screw System
Synchro Medical
Orthopedic
88d
Cleared
Aug 04, 2015
ForeFoot STP System
Tornier, Inc.
Orthopedic
125d
Cleared
Jul 24, 2015
N-Force Fixation System
Innovision, Inc.
Orthopedic
86d