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., Wrightmedicaltechnologyinc and Synthes (Usa).

1059
Total
1059
Cleared
115d
Avg days
1977
Since
Declining activity - 33 submissions in the last 2 years vs 47 in the prior period
Consistent review times: 118d avg (recent)

FDA 510(k) Cleared Screw, Fixation, Bone Devices (Product Code HWC)

1059 devices
1–24 of 1059
Cleared Jun 05, 2026
VEOFIX Snap Off Screw
K253108
Steps Ortho
Orthopedic · 254d
Cleared May 30, 2026
CoLink® & CoLag® Non-Sterile Screws
K261154
In2bones USA, LLC
Orthopedic · 52d
Cleared May 14, 2026
TriMed Compression Screws
K261241
TriMed, Inc.
Orthopedic · 29d
Cleared May 08, 2026
Arthrex Beaming System
K254215
Arthrex, Inc.
Orthopedic · 130d
Cleared May 01, 2026
OSSIOfiber® Threaded Trimmable Fixation Nail
K254077
OSSIO , Ltd.
Orthopedic · 134d
Cleared Apr 17, 2026
TITAN Nail
K260934
Medartis AG
Orthopedic · 28d
Cleared Apr 10, 2026
CoAptix S System
K252699
University of Utah, Department of Orthopaedics
Orthopedic · 226d
Cleared Apr 03, 2026
Tyber Medical Trauma Screw
K253042
Tyber Medical, LLC
Orthopedic · 193d
Cleared Mar 18, 2026
DynaNail Mini
K254110
MedShape, Inc.
Orthopedic · 89d
Cleared Mar 06, 2026
Treace Medical Concepts (TMC) Screw Fixation System
K260361
Treace Medical Concepts, Inc.
Orthopedic · 30d
Cleared Dec 31, 2025
Tyber Medical Trauma Screw
K252901
Tyber Medical, LLC
Orthopedic · 111d
Cleared Nov 06, 2025
Ultra™ Compression Screw System
K251555
Pace Surgical
Orthopedic · 169d
Cleared Oct 10, 2025
Eleganz IM Threaded Nail System (IM Threaded Nail System)
K252312
Dev4
Orthopedic · 78d
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

About Product Code HWC - Regulatory Context

510(k) Submission Activity

1059 total 510(k) submissions under product code HWC since 1977, with 1059 receiving FDA clearance (average review time: 115 days).

Submission volume has declined in recent years - 33 submissions in the last 24 months compared to 47 in the prior period.

FDA 510(k) Review Time - HWC Product Code

FDA review times for HWC submissions have been consistent, averaging 118 days recently vs 115 days historically.

HWC devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →