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., Wrightmedicaltechnologyinc and Synthes (Usa).
1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
Cleared
Apr 20, 2018
SafetyFix EasyOut System
Safetyfix Medical Technologies, Inc.
Orthopedic
29d
Cleared
Feb 12, 2018
MotoBAND CP Implant System
Crossroads Extremity Systems, LLC
Orthopedic
70d
Cleared
Feb 07, 2018
G-Beam Fusion Beaming System
Orthofix Srl
Orthopedic
153d
Cleared
Jan 12, 2018
HBS2 Headless Bone Screw
Stuckenbrock Medizintechnik GmbH
Orthopedic
224d
Cleared
Dec 14, 2017
Cannulated Screw Internal Fixation System
Life Spine, Inc.
Orthopedic
59d
Cleared
Aug 18, 2017
Medline UNITE® Snap-Off Screws
Medline Industries, Inc.
Orthopedic
156d
Cleared
Jul 07, 2017
Hammertoe Correction System
Life Spine, Inc.
Orthopedic
51d
Cleared
Jun 09, 2017
2-Piece Hammertoe Correction System
Life Spine, Inc.
Orthopedic
256d
Cleared
May 11, 2017
Arthrex Compression Screws
Arthrex, Inc.
Orthopedic
93d
Cleared
May 01, 2017
CAPTIVATE™ Compression Screws
Globus Medical, Inc.
Orthopedic
206d
Cleared
Apr 26, 2017
HV Screw System
Wrightmedicaltechnologyinc
Orthopedic
33d
Cleared
Apr 13, 2017
MICATM Screw System
Wrightmedicaltechnologyinc
Orthopedic
233d
Cleared
Mar 09, 2016
Biomet Variable Pitch Compression Screw System
Biomet, Inc.
Orthopedic
57d
Cleared
Nov 24, 2015
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
Zimmer, Inc.
Orthopedic
56d
Cleared
Sep 04, 2015
PRO-TOE Hammertoe Fixation System
Wrightmedicaltechnologyinc
Orthopedic
60d
Cleared
May 15, 2015
Arthrex RetroFusion Screw
Arthrex, Inc.
Orthopedic
23d
Cleared
May 08, 2015
Subtalar Spacer System (STS)
Wrightmedicaltechnologyinc
Orthopedic
98d
Cleared
Apr 29, 2015
PHALINX Hammertoe System
Wrightmedicaltechnologyinc
Orthopedic
85d
Cleared
Mar 31, 2015
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
Zimmer, Inc.
Orthopedic
148d
Cleared
Jan 23, 2015
Cannulated Screw System
Wrightmedicaltechnologyinc
Orthopedic
50d
Cleared
Jan 16, 2015
Arthrex Low Profile Screws
Arthrex, Inc.
Orthopedic
28d
Cleared
Nov 20, 2014
PhaLinx Hammertoe System
Wrightmedicaltechnologyinc
Orthopedic
66d
Cleared
Oct 03, 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
Zimmer, Inc.
Orthopedic
31d
Cleared
Jun 03, 2014
BIOMET CANNULATED SCREW SYSTEM
Biomet, Inc.
Orthopedic
56d