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).
1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
Cleared
Jul 22, 2021
Medline UNITE® Digital Fusion Screw System
Medline Industries, Inc.
Orthopedic
29d
Cleared
Jun 01, 2021
Arthrex Beveled FT Screws
Arthrex, Inc.
Orthopedic
60d
Cleared
May 28, 2021
Axis Charcot Fixation System
Extremity Medical, LLC
Orthopedic
32d
Cleared
May 11, 2021
DART-FIRE EDGE Cannulated Screw System
Wright Medical
Orthopedic
190d
Cleared
Apr 14, 2021
Cannulated Fasteners and Nuts
OsteoCentric Technologies
Orthopedic
30d
Cleared
Feb 26, 2021
LTJ Screws and Washer
Azurmeds, Inc.
Orthopedic
25d
Cleared
Jan 15, 2021
Dynanail Mini Hybrid
MedShape, Inc.
Orthopedic
59d
Cleared
Jan 13, 2021
Inion CompressOn Screw
Inion OY
Orthopedic
90d
Cleared
Jan 05, 2021
Fixone Biocomposite Interference Screw
Aju Pharm Co., Ltd.
Orthopedic
385d
Cleared
Dec 30, 2020
Arthrex Low Profile Screws
Arthrex, Inc.
Orthopedic
57d
Cleared
Dec 23, 2020
WishBone Medical Plate and Screw System
Wishbone Medical, Inc.
Orthopedic
28d
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