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.
1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
Cleared
Mar 10, 2022
SIGNUS SACRONAIL® Transsacral Stabilization System
Signus Medizintechnik GmbH
Orthopedic
191d
Cleared
Feb 03, 2022
MectaScrew Extension
Medacta International S.A.
Orthopedic
448d
Cleared
Jan 31, 2022
MIS Precision Chevron Bunion System
Relja Innovations, LLC
Orthopedic
249d
Cleared
Jan 18, 2022
JuniOrtho Plating System™
Orthofix Srl
Orthopedic
69d
Cleared
Jan 14, 2022
BRM TOOL Screws
Brm Extremities Srl
Orthopedic
387d
Cleared
Jan 11, 2022
Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System
Stryker GmbH
Orthopedic
104d
Cleared
Jan 04, 2022
DynaFuse Fixation System
MedShape, Inc.
Orthopedic
391d
Cleared
Dec 30, 2021
Quick-Start Screws
Innovate Orthopaedics Limited
Orthopedic
139d
Cleared
Dec 25, 2021
R3ACT Stabilization System
Paragon 28, Inc.
Orthopedic
200d
Cleared
Dec 21, 2021
InCore Subtalar System
Nextremity Solutions, Inc.
Orthopedic
81d
Cleared
Dec 21, 2021
OSSIOfiber Compression Screw, 3.5mm
OSSIO , Ltd.
Orthopedic
39d
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