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
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
Cleared
Jul 15, 2015
OsteoMed Cannulated Screw System
Osteomed Corp.
Orthopedic
90d
Cleared
Jul 15, 2015
Monster Screw System
Paragon 28
Orthopedic
48d
Cleared
Jun 23, 2015
SMV Scientific Bone Screws
Smv Scientific
Orthopedic
70d
Cleared
Jun 12, 2015
Sonoma Cancellous Bone Screw and Washer
Sonoma Orthopedics Products, Inc.
Orthopedic
119d
Cleared
Jun 04, 2015
ToeTac Hammertoe Fixation System
Restore Surgical, LLC Dba Instratek
Orthopedic
104d
Cleared
May 26, 2015
Biomet Microfixation RibFix Blu Thoracic Fixation System
Biomet Microfixation
Orthopedic
25d