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).
1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
Cleared
Nov 03, 2023
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
Medartis AG
Orthopedic
98d
Cleared
Oct 12, 2023
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
Paragon 28, Inc.
Orthopedic
167d
Cleared
Sep 29, 2023
Intraosseous Fusion Device System
Auxano Medical, LLC
Orthopedic
115d
Cleared
Sep 15, 2023
Accelerate Compression Screw System-Small Product Code ACC-S
Trax Surgical
Orthopedic
164d
Cleared
Sep 11, 2023
TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
Vilex, LLC
Orthopedic
110d
Cleared
Sep 05, 2023
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
Innovate Orthopaedics Limited
Orthopedic
76d
Cleared
Aug 30, 2023
Nexis® compressive screws
Novastep
Orthopedic
286d
Cleared
Jul 27, 2023
IBS-B MIS Beveled Screw System
In2bones USA, LLC
Orthopedic
90d
Cleared
Jul 18, 2023
Forma Medical Headless Compression Screw
Forma Medical, Inc.
Orthopedic
105d
Cleared
Jun 29, 2023
OsteoCentric ACL Fixation System
OsteoCentric Technologies
Orthopedic
118d
Cleared
Jun 26, 2023
Bone Bolt System
University of Utah, Department of Orthopaedics
Orthopedic
89d
Cleared
Jun 12, 2023
Cut Screw - Percutaneous Compression Screw
GM Dos Reis Industria e Comercio Ltda.
Orthopedic
118d
Cleared
Jun 09, 2023
Acumed Acutrak 3 Headless Compression Screw System
Acumed, LLC
Orthopedic
84d
Cleared
Apr 28, 2023
Hand Trauma Threaded Nail System
Skeletal Dynamics, Inc.
Orthopedic
28d
Cleared
Apr 19, 2023
SimpliFix Hip System
Stabiliz Orthopaedics, Inc.
Orthopedic
103d
Cleared
Apr 17, 2023
TriMed Threaded Intramedullary Nail System
TriMed, Inc.
Orthopedic
31d
Cleared
Feb 28, 2023
REVCON (TM) Screw System
Voom Medical Devices, Inc.
Orthopedic
112d
Cleared
Feb 17, 2023
PROstep(TM) MIS 5mm Chamfer Screw System
Wright Medical Technology
Orthopedic
256d
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