HWC · Class II · 21 CFR 888.3040

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., Synthes (Usa) and Wrightmedicaltechnologyinc.

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
25–48 of 1070
Cleared Oct 08, 2025
MetaFore Small Screw System
K250536
Extremity Medical, LLC
Orthopedic · 226d
Cleared Oct 02, 2025
Cannulated Screw and Kirschner (K wire) System
K252758
Orthonovis, Inc.
Orthopedic · 34d
Cleared Aug 29, 2025
CurvaFix Low Profile System
K252019
Curvafix, Inc.
Orthopedic · 60d
Cleared Aug 27, 2025
Phoenix Sinus Tarsi Stent System
K251382
Astra Orthomed, Inc.
Orthopedic · 117d
Cleared Aug 15, 2025
Dunamis Screw and Suture Locking System
K250867
Dunamis Medical, LLC
Orthopedic · 144d
Cleared Jun 13, 2025
Eleganz Fusion Screw System (Fusion Screw System)
K250251
Dev4
Orthopedic · 136d
Cleared Apr 10, 2025
TriMed® Compression Screws
K243943
TriMed, Inc.
Orthopedic · 111d
Cleared Apr 02, 2025
SnapHammer Hammertoe Correction System
K250613
Nvision Biomedical Technologies, Inc.
Orthopedic · 33d
Cleared Mar 05, 2025
TITANEX Screw Systems
K250304
Vilex, LLC
Orthopedic · 30d
Cleared Feb 05, 2025
Caliber Intramedullary Fixation System
K242896
Nvision Biomedical Technologies
Orthopedic · 135d
Cleared Jan 31, 2025
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
K242442
Innovate Orthopaedics, Ltd.
Orthopedic · 168d
Cleared Jan 10, 2025
Arthrex SS VAL and VAL KreuLock™ Compression Screw System
K243195
Arthrex, Inc.
Orthopedic · 101d
Cleared Dec 04, 2024
Locking Screw,CoCrMo
K242348
Double Medical Technology, Inc.
Orthopedic · 118d
Cleared Nov 22, 2024
OsteoCoil™ Nitinol Compression System (Multiple Component PNs)
K233567
Flower Orthopedics Corporation Dba Conventus Flower Ortho
Orthopedic · 382d
Cleared Oct 29, 2024
Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
K240175
Tigon Medical
Orthopedic · 280d
Cleared Oct 09, 2024
OsteoCentric Technologies Cannulated Fasteners and Nuts
K242691
OsteoCentric Technologies
Orthopedic · 30d
Cleared Oct 04, 2024
Treace Medical Concepts (TMC) Screw Fixation System
K242671
Treace Medical Concepts, Inc.
Orthopedic · 28d
Cleared Aug 31, 2024
Arthrex VAL and VAL KreuLock™ Compression Screw System
K241592
Arthrex, Inc.
Orthopedic · 89d
Cleared Aug 02, 2024
Medline UNITE® MIS Foot Recon Screw System
K241359
Medline Industries, LP
Orthopedic · 80d
Cleared Jul 03, 2024
OSSIOfiber® Threaded Trimmable Fixation Nail
K241277
OSSIO , Ltd.
Orthopedic · 58d
Cleared Jun 13, 2024
Arthrex Cannulated Screw System
K240815
Arthrex, Inc.
Orthopedic · 80d
Cleared Jun 05, 2024
Cannulated Headless Bone Screws
K233008
Aap Implantate AG
Orthopedic · 257d
Cleared Mar 21, 2024
DynaNail Mini Tapered Hybrid
K240530
MedShape, Inc.
Orthopedic · 27d
Cleared Mar 11, 2024
ARIX Cannulated Screw System
K233912
Jeil Medical Corporation
Orthopedic · 90d