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., TriMed, Inc. and Nvision Biomedical Technologies, Inc..
1055
Total
1055
Cleared
115d
Avg days
1977
Since
1055 devices
Cleared
Oct 09, 2024
OsteoCentric Technologies Cannulated Fasteners and Nuts
OsteoCentric Technologies
Orthopedic
30d
Cleared
Oct 04, 2024
Treace Medical Concepts (TMC) Screw Fixation System
Treace Medical Concepts, Inc.
Orthopedic
28d
Cleared
Aug 31, 2024
Arthrex VAL and VAL KreuLock™ Compression Screw System
Arthrex, Inc.
Orthopedic
89d
Cleared
Aug 02, 2024
Medline UNITE® MIS Foot Recon Screw System
Medline Industries, LP
Orthopedic
80d
Cleared
Jul 03, 2024
OSSIOfiber® Threaded Trimmable Fixation Nail
OSSIO , Ltd.
Orthopedic
58d
Cleared
Jun 13, 2024
Arthrex Cannulated Screw System
Arthrex, Inc.
Orthopedic
80d
Cleared
Jun 05, 2024
Cannulated Headless Bone Screws
Aap Implantate AG
Orthopedic
257d
Cleared
Mar 21, 2024
DynaNail Mini Tapered Hybrid
MedShape, Inc.
Orthopedic
27d
Cleared
Mar 11, 2024
ARIX Cannulated Screw System
Jeil Medical Corporation
Orthopedic
90d
Cleared
Mar 08, 2024
OSSIOfiber® Threaded Trimmable Fixation Nails
OSSIO , Ltd.
Orthopedic
162d
Cleared
Feb 16, 2024
SnapHammer Hammertoe Correction System
Nvision Biomedical Technologies, Inc.
Orthopedic
274d
Cleared
Jan 18, 2024
TDM Screw System
Tdm Co., Ltd.
Orthopedic
209d
Cleared
Jan 18, 2024
TriMed Threaded Intramedullary Nail System
TriMed, Inc.
Orthopedic
28d
Cleared
Jan 04, 2024
Zimed Distal Medial Tibial Plate and Screw System
Zimed Medikal
Orthopedic
314d
Cleared
Dec 21, 2023
Cannulated Screw System
Smith & Nephew, Inc.
Orthopedic
79d
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 11, 2023
TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
Vilex, LLC
Orthopedic
110d
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
Jun 29, 2023
OsteoCentric ACL Fixation System
OsteoCentric Technologies
Orthopedic
118d
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