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
Dec 09, 2021
Nextra CH Cannulated Hammertoe System
Nextremity Solutions, Inc.
Orthopedic
34d
Cleared
Nov 19, 2021
Vector® Hammertoe Correction System
Nvision Biomedical Technologies, Inc.
Orthopedic
30d
Cleared
Nov 16, 2021
Sterile PHALINX Hammertoe System
Wrightmedicaltechnologyinc
Orthopedic
57d
Cleared
Nov 09, 2021
BESPA Charcot System
Bespa Global, LLC
Orthopedic
449d
Cleared
Oct 21, 2021
Treace Medical Concepts (TMC) Screw Fixation System
Treace Medical Concepts, Inc.
Orthopedic
30d
Cleared
Oct 05, 2021
ChM 4.5mm Cortical screws
Chm Sp. Z O.O.
Orthopedic
228d
Cleared
Sep 23, 2021
Nexta PEEK Hammertoe Correction System
Nextremity Solutions, Inc.
Orthopedic
87d
Cleared
Aug 25, 2021
Auxein Nailing System
Auxein Medical Private Limited
Orthopedic
163d
Cleared
Aug 20, 2021
Auxilock Titanium Interference Screw
Auxein Medical Private Limited
Orthopedic
322d
Cleared
Aug 06, 2021
PAO Cortical Screw
Medacta International S.A.
Orthopedic
88d
Cleared
Aug 06, 2021
TriMed Threaded Intramedullary Nail System
TriMed, Inc.
Orthopedic
58d
Cleared
Aug 03, 2021
Cannulated Fasteners and Nuts
OsteoCentric Technologies
Orthopedic
97d
Cleared
Jul 23, 2021
IntraLock System
Fusion Orthopedics, LLC
Orthopedic
183d
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