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.

1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
169–192 of 1059
Cleared Mar 12, 2019
ActivOrtho Nitinol Compression Screw System
K181610
Activortho, Inc.
Orthopedic · 266d
Cleared Mar 12, 2019
INnate Cannulated Screw System
K183603
Exsomed Corporation
Orthopedic · 76d
Cleared Mar 01, 2019
CurvaFix Intramedullary Rodscrew System
K180050
Curvafix, Inc.
Orthopedic · 417d
Cleared Feb 19, 2019
Vector Hammertoe Correction System
K183055
Nvision Biomedical Technologies, LLC
Orthopedic · 109d
Cleared Feb 14, 2019
DynaNail Mini
K182677
MedShape, Inc.
Orthopedic · 141d
Cleared Feb 07, 2019
Biomet Headless Compression and Twist-Off Screws
K190035
Biomet, Inc.
Orthopedic · 30d
Cleared Jan 22, 2019
EZStart Interference Screw
K182955
Conmed Corporation
Orthopedic · 90d
Cleared Jan 11, 2019
PROSTEP MICA Screw System
K181377
Wrightmedicaltechnologyinc
Orthopedic · 232d
Cleared Dec 18, 2018
Arthrex Compression FT Screws
K182361
Arthrex, Inc.
Orthopedic · 110d
Cleared Dec 18, 2018
AURORA™ Screw System
K182989
MiRus, LLC
Orthopedic · 50d
Cleared Dec 07, 2018
ICONN Campbell Interference Screw
K180670
Iconn Orthopedics, LLC
Orthopedic · 268d
Cleared Dec 04, 2018
Healix™ Compression Screw System
K182949
Nvision Biomedical Technologies, LLC
Orthopedic · 42d
Cleared Nov 23, 2018
Responsive Arthroscopy Interference Screw System
K180573
Responsive Arthroscopy, LLC
Orthopedic · 263d
Cleared Nov 23, 2018
HammerTechTM Fixation System
K182684
Fusion Orthopedics, LLC
Orthopedic · 58d
Cleared Nov 21, 2018
DePuy Synthes 2.0 mm Quick Insertion Screws
K180541
Synthes USA Products, LLC
Orthopedic · 265d
Cleared Oct 26, 2018
Two-Step Implant System
K181898
Trilliant Surgical
Orthopedic · 102d
Cleared Sep 07, 2018
SILVERBACK Gorilla Plating System
K182148
Paragon 28, Inc.
Orthopedic · 30d
Cleared Jul 17, 2018
Field Orthopaedics Micro Screw System
K180348
Field Orthopaedics Pty, Ltd.
Orthopedic · 159d
Cleared Jul 13, 2018
Injection Screw
K173556
Biedermann Medtech, Inc.
Orthopedic · 238d
Cleared Jul 11, 2018
SALVATION Midfoot Nail
K180024
Wrightmedicaltechnologyinc
Orthopedic · 189d
Cleared Jun 20, 2018
Fracture and Correction System
K180377
In2bones USA, LLC
Orthopedic · 128d
Cleared Jun 04, 2018
VariAx 2 System
K180500
Stryker GmbH
Orthopedic · 98d
Cleared May 09, 2018
Diamond Orthopedic Bone Fixation Screws and Pins
K180932
Diamond Orthopedic, LLC
Orthopedic · 29d
Cleared Apr 25, 2018
InCore® Lapidus System
K180257
Nextremity Solutions, Inc.
Orthopedic · 85d