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
Dec 16, 2020
CREED™ Cannulated Screws
Glw Medical, Inc.
Orthopedic
315d
Cleared
Nov 13, 2020
Monster Screw System
Paragon 28, Inc.
Orthopedic
43d
Cleared
Nov 06, 2020
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
Medartis AG
General Hospital
59d
Cleared
Oct 22, 2020
GEO Bone Screw System
Gramercy Extremity Orthopedics, LLC
Orthopedic
28d
Cleared
Oct 15, 2020
OsteoMed ExtremiFix Mini & Small Cannulated Screw System
Osteomed, LLC
Orthopedic
30d
Cleared
Sep 23, 2020
Responsive Arthroscopy Interference Screw System
Responsive Arthroscopy, LLC
Orthopedic
19d
Cleared
Sep 22, 2020
LTJ Screws and Washer
Azurmeds, Inc.
Orthopedic
160d
Cleared
Aug 04, 2020
Vector Hammertoe Correction System
Nvision Biomedical Technologies, Inc.
Orthopedic
29d
Cleared
Jul 30, 2020
OSSIOfiber™ Compression Screws
OSSIO , Ltd.
Orthopedic
213d
Cleared
Jul 16, 2020
REDUCT® Headless Compression Screw System
Skeletal Dynamics, Inc.
Orthopedic
27d
Cleared
Jul 08, 2020
Intraosseous Fixation System
Extremity Medical, LLC
Orthopedic
28d
Cleared
Jun 26, 2020
RetroFix
Retrofix Screws, LLC
Orthopedic
148d
Cleared
Jun 26, 2020
DuoHex CH Cannulated Hammertoe System
Nextremity Solutions, Inc.
Orthopedic
87d
Cleared
Jun 20, 2020
InFrame™ Cannulated Fixation System
Exsomed Corp.
Orthopedic
19d
Cleared
Jun 17, 2020
Medline UNITE Jones Fracture Screw System
Medline Industires, Inc.
Orthopedic
30d
Cleared
May 13, 2020
InCore MPJ System
Nextremity Solutions, Inc.
Orthopedic
113d
Cleared
May 05, 2020
Healix Compression Screw System
Nvision Biomedical Technologies, Inc.
Orthopedic
29d
Cleared
May 04, 2020
Headless Compression Screw System
Osteocentric Extremities, LLC
Orthopedic
91d
Cleared
Apr 18, 2020
S4 Screw System
Subchondral Solutions, Inc.
Orthopedic
267d
Cleared
Mar 20, 2020
T2 ICF
Stryker GmbH
Orthopedic
107d
Cleared
Mar 19, 2020
restor3d Metallic Interference Screw
Restor3d
Orthopedic
93d
Cleared
Feb 27, 2020
Omnia Medical Trauma Screws
Omnia Medical, LLC
Orthopedic
206d
Cleared
Feb 24, 2020
Titanium Interference Screws
Biomet, Inc.
Orthopedic
73d
Cleared
Feb 10, 2020
Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
Arthrex, Inc.
Orthopedic
88d