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
Feb 16, 2023
Bony Trauma Extremity System (BTES) Screw Range, NX Nail
Field Orthopaedics Pty, Ltd.
Orthopedic
30d
Cleared
Feb 13, 2023
OIC Intramedullary Screw System
Orthopaedic Implant Company
Orthopedic
60d
Cleared
Jan 25, 2023
CREED™ Cannulated Screws
Glw, Inc.
Orthopedic
34d
Cleared
Jan 10, 2023
Metal Cannulated Screw
Double Medical Technology, Inc.
Orthopedic
272d
Cleared
Jan 10, 2023
Haymaker® Screw System
Orthocircle Spine D.B.A. OC Medical Devices
Orthopedic
116d
Cleared
Dec 29, 2022
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
Acumed, LLC
Orthopedic
234d
Cleared
Dec 23, 2022
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
OSSIO , Ltd.
Orthopedic
242d
Cleared
Dec 16, 2022
BRM TOOL Screws, BIOPLAN Subtalar Implant
Brm Extremities
Orthopedic
88d
Cleared
Dec 16, 2022
Phantom Metatarsal Shortening System
Paragon 28, Inc.
Orthopedic
65d
Cleared
Dec 13, 2022
REDEMPTION Beaming System
Vilex, LLC
Orthopedic
218d
Cleared
Dec 12, 2022
Metal Bone Screw
Double Medical Technology, Inc.
Orthopedic
257d
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