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., Wrightmedicaltechnologyinc and Synthes (Usa).

1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
193–216 of 1059
Cleared Apr 20, 2018
SafetyFix EasyOut System
K180753
Safetyfix Medical Technologies, Inc.
Orthopedic · 29d
Cleared Feb 12, 2018
MotoBAND CP Implant System
K173710
Crossroads Extremity Systems, LLC
Orthopedic · 70d
Cleared Feb 07, 2018
G-Beam Fusion Beaming System
K172698
Orthofix Srl
Orthopedic · 153d
Cleared Jan 12, 2018
HBS2 Headless Bone Screw
K171628
Stuckenbrock Medizintechnik GmbH
Orthopedic · 224d
Cleared Dec 14, 2017
Cannulated Screw Internal Fixation System
K173286
Life Spine, Inc.
Orthopedic · 59d
Cleared Aug 18, 2017
Medline UNITE® Snap-Off Screws
K170782
Medline Industries, Inc.
Orthopedic · 156d
Cleared Jul 07, 2017
Hammertoe Correction System
K171448
Life Spine, Inc.
Orthopedic · 51d
Cleared Jun 09, 2017
2-Piece Hammertoe Correction System
K162685
Life Spine, Inc.
Orthopedic · 256d
Cleared May 11, 2017
Arthrex Compression Screws
K170382
Arthrex, Inc.
Orthopedic · 93d
Cleared May 01, 2017
CAPTIVATE™ Compression Screws
K162825
Globus Medical, Inc.
Orthopedic · 206d
Cleared Apr 26, 2017
HV Screw System
K170889
Wrightmedicaltechnologyinc
Orthopedic · 33d
Cleared Apr 13, 2017
MICATM Screw System
K162353
Wrightmedicaltechnologyinc
Orthopedic · 233d
Cleared Mar 09, 2016
Biomet Variable Pitch Compression Screw System
K160058
Biomet, Inc.
Orthopedic · 57d
Cleared Nov 24, 2015
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
K152841
Zimmer, Inc.
Orthopedic · 56d
Cleared Sep 04, 2015
PRO-TOE Hammertoe Fixation System
K151838
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared May 15, 2015
Arthrex RetroFusion Screw
K151078
Arthrex, Inc.
Orthopedic · 23d
Cleared May 08, 2015
Subtalar Spacer System (STS)
K150213
Wrightmedicaltechnologyinc
Orthopedic · 98d
Cleared Apr 29, 2015
PHALINX Hammertoe System
K150252
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
K143165
Zimmer, Inc.
Orthopedic · 148d
Cleared Jan 23, 2015
Cannulated Screw System
K143460
Wrightmedicaltechnologyinc
Orthopedic · 50d
Cleared Jan 16, 2015
Arthrex Low Profile Screws
K143614
Arthrex, Inc.
Orthopedic · 28d
Cleared Nov 20, 2014
PhaLinx Hammertoe System
K142585
Wrightmedicaltechnologyinc
Orthopedic · 66d
Cleared Oct 03, 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442
Zimmer, Inc.
Orthopedic · 31d
Cleared Jun 03, 2014
BIOMET CANNULATED SCREW SYSTEM
K140891
Biomet, Inc.
Orthopedic · 56d