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).

1070
Total
1070
Cleared
115d
Avg days
1977
Since
Stable submission activity - 38 submissions in the last 2 years
Consistent review times: 125d avg (recent)

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

1070 devices
1–24 of 1070
Cleared Oct 14, 2026
Ntegrate Threaded Nail System
K261961
Nvision Biomedical Technologies
Orthopedic · 125d
Cleared Oct 02, 2026
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts
K263116
OsteoCentric Technologies
Orthopedic · 28d
Cleared Sep 25, 2026
Arthrex Beaming System
K262975
Arthrex, Inc.
Orthopedic · 30d
Cleared Sep 23, 2026
DynaNail Helix® Fixation System
K260995
MedShape, Inc.
Orthopedic · 181d
Cleared Sep 21, 2026
F.A.S.T Screw
K254280
Steps Ortho
Orthopedic · 265d
Cleared Sep 04, 2026
ActivaScrew™ Cannulated COM
K261057
Bioretec, Ltd.
Orthopedic · 157d
Cleared Aug 24, 2026
OsteoCoil™ GT Active Compression System
K260106
Flower Orthopedics Corporation DBA Conventus Flower Orthoped
Orthopedic · 222d
Cleared Aug 12, 2026
Large Compression Screws
K262344
TriMed, Inc.
Orthopedic · 33d
Cleared Aug 05, 2026
GFS - Sterile Screws and Top Hat
K253858
T.A.G. Medical Products Corporation, Ltd.
Orthopedic · 245d
Cleared Jul 22, 2026
Lapidus Screw Kit
K262075
Relja Innovations, LLC
Orthopedic · 30d
Cleared Jun 25, 2026
Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
K260809
Arthrex, Inc.
Orthopedic · 105d
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

About Product Code HWC - Regulatory Context

510(k) Submission Activity

1070 total 510(k) submissions under product code HWC since 1977, with 1070 receiving FDA clearance (average review time: 115 days).

Submission volume has remained relatively stable over the observed period, with 38 submissions in the last 24 months.

FDA 510(k) Review Time - HWC Product Code

FDA review times for HWC submissions have been consistent, averaging 125 days recently vs 115 days historically.

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