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.

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
169–192 of 1064
Cleared Apr 17, 2019
Arthrex 2.5 mm Tenodesis Screw
K183395
Arthrex, Inc.
Orthopedic · 131d
Cleared Apr 03, 2019
Monster® Screw System
K190586
Paragon 28, Inc.
Orthopedic · 28d
Cleared Mar 26, 2019
Arthrex TensionLoc System
K183628
Arthrex, Inc.
Orthopedic · 90d
Cleared Mar 22, 2019
OsteoCentric Bone Plate and Screw System
K190430
Osteocentric Trauma
Orthopedic · 28d
Cleared Mar 13, 2019
Wright Jones Fracture System
K183026
Wrightmedicaltechnologyinc
Orthopedic · 132d
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