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