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.

1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
25–48 of 1059
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
Cleared Mar 08, 2024
OSSIOfiber® Threaded Trimmable Fixation Nails
K233198
OSSIO , Ltd.
Orthopedic · 162d
Cleared Feb 16, 2024
SnapHammer Hammertoe Correction System
K231453
Nvision Biomedical Technologies, Inc.
Orthopedic · 274d
Cleared Jan 18, 2024
TDM Screw System
K231860
Tdm Co., Ltd.
Orthopedic · 209d
Cleared Jan 18, 2024
TriMed Threaded Intramedullary Nail System
K234040
TriMed, Inc.
Orthopedic · 28d
Cleared Jan 04, 2024
Zimed Distal Medial Tibial Plate and Screw System
K230507
Zimed Medikal
Orthopedic · 314d
Cleared Dec 21, 2023
Cannulated Screw System
K233396
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Nov 03, 2023
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
K232251
Medartis AG
Orthopedic · 98d
Cleared Oct 12, 2023
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
K231231
Paragon 28, Inc.
Orthopedic · 167d
Cleared Sep 29, 2023
Intraosseous Fusion Device System
K231649
Auxano Medical, LLC
Orthopedic · 115d
Cleared Sep 15, 2023
Accelerate Compression Screw System-Small Product Code ACC-S
K230946
Trax Surgical
Orthopedic · 164d
Cleared Sep 11, 2023
TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
K231504
Vilex, LLC
Orthopedic · 110d