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
Apr 10, 2025
TriMed® Compression Screws
TriMed, Inc.
Orthopedic
111d
Cleared
Apr 02, 2025
SnapHammer Hammertoe Correction System
Nvision Biomedical Technologies, Inc.
Orthopedic
33d
Cleared
Mar 05, 2025
TITANEX Screw Systems
Vilex, LLC
Orthopedic
30d
Cleared
Feb 05, 2025
Caliber Intramedullary Fixation System
Nvision Biomedical Technologies
Orthopedic
135d
Cleared
Jan 31, 2025
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
Innovate Orthopaedics, Ltd.
Orthopedic
168d
Cleared
Jan 10, 2025
Arthrex SS VAL and VAL KreuLock™ Compression Screw System
Arthrex, Inc.
Orthopedic
101d
Cleared
Dec 04, 2024
Locking Screw,CoCrMo
Double Medical Technology, Inc.
Orthopedic
118d
Cleared
Nov 22, 2024
OsteoCoil™ Nitinol Compression System (Multiple Component PNs)
Flower Orthopedics Corporation Dba Conventus Flower Ortho
Orthopedic
382d
Cleared
Oct 29, 2024
Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
Tigon Medical
Orthopedic
280d
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