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
Nov 23, 2022
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
Avanti Orthopaedics, Inc.
Orthopedic
57d
Cleared
Nov 15, 2022
Treace Medical Concepts (TMC) Hammertoe Fixation System
Treace Medical Concepts, Inc.
Orthopedic
83d
Cleared
Nov 04, 2022
Nextra CH Cannulated Hammertoe System
Nextremity Solutions, Inc.
Orthopedic
154d
Cleared
Oct 27, 2022
CurvaFix IM System
Curvafix, Inc.
Orthopedic
70d
Cleared
Sep 20, 2022
Tandry Compression Screw System
Microware Precision Co., Ltd.
Orthopedic
224d
Cleared
Sep 19, 2022
Arthrex Compression FT Pins
Arthrex, Inc.
Orthopedic
180d
Cleared
Sep 08, 2022
CAPTIVATE® Compression Screws
Globus Medical, Inc.
Orthopedic
29d
Cleared
Aug 03, 2022
Cannulated Screws
Maxxion Medical, LLC
Orthopedic
261d
Cleared
Jun 10, 2022
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
Stryker GmbH
Orthopedic
127d
Cleared
May 12, 2022
Hand Trauma Screw System
Skeletal Dynamics, Inc.
Orthopedic
59d
Cleared
Apr 27, 2022
ExsoMed INnate NanoTM Lag Screw System
Exsomed Corp.
Orthopedic
30d
Cleared
Apr 13, 2022
Cannulated Compression Device System
Orthopedic Designs North America, Inc.
Orthopedic
447d
Cleared
Mar 22, 2022
Medline UNITE IM Fibula Implant
Medline Industries, LP
Orthopedic
28d
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