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
265–288 of 1070
Cleared Mar 09, 2016
Biomet Variable Pitch Compression Screw System
K160058
Biomet, Inc.
Orthopedic · 57d
Cleared Mar 02, 2016
RECON system - Compression Screws
K151708
Normed Medizin-Technik GmbH
Orthopedic · 252d
Cleared Feb 26, 2016
Tyber Medical Trauma Screw
K153575
Tyber Medical, LLC
Orthopedic · 73d
Cleared Feb 25, 2016
SIGN Compression Screw System
K153759
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
K152187
Merete Medical GmbH
Orthopedic · 191d
Cleared Feb 05, 2016
MINIARS SCREWS
K143596
Overmed Srl.
Orthopedic · 414d
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