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
1059 devices
73–96 of 1059
Cleared Nov 23, 2022
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
K222967
Avanti Orthopaedics, Inc.
Orthopedic · 57d
Cleared Nov 15, 2022
Treace Medical Concepts (TMC) Hammertoe Fixation System
K222564
Treace Medical Concepts, Inc.
Orthopedic · 83d
Cleared Nov 04, 2022
Nextra CH Cannulated Hammertoe System
K221610
Nextremity Solutions, Inc.
Orthopedic · 154d
Cleared Oct 27, 2022
CurvaFix IM System
K222505
Curvafix, Inc.
Orthopedic · 70d
Cleared Sep 20, 2022
Tandry Compression Screw System
K220359
Microware Precision Co., Ltd.
Orthopedic · 224d
Cleared Sep 19, 2022
Arthrex Compression FT Pins
K220839
Arthrex, Inc.
Orthopedic · 180d
Cleared Sep 08, 2022
CAPTIVATE® Compression Screws
K222409
Globus Medical, Inc.
Orthopedic · 29d
Cleared Aug 03, 2022
Cannulated Screws
K213614
Maxxion Medical, LLC
Orthopedic · 261d
Cleared Jun 10, 2022
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
K220319
Stryker GmbH
Orthopedic · 127d
Cleared May 12, 2022
Hand Trauma Screw System
K220723
Skeletal Dynamics, Inc.
Orthopedic · 59d
Cleared Apr 27, 2022
ExsoMed INnate NanoTM Lag Screw System
K220892
Exsomed Corp.
Orthopedic · 30d
Cleared Apr 13, 2022
Cannulated Compression Device System
K210146
Orthopedic Designs North America, Inc.
Orthopedic · 447d
Cleared Mar 22, 2022
Medline UNITE IM Fibula Implant
K220511
Medline Industries, LP
Orthopedic · 28d
Cleared Mar 10, 2022
SIGNUS SACRONAIL® Transsacral Stabilization System
K212755
Signus Medizintechnik GmbH
Orthopedic · 191d
Cleared Feb 03, 2022
MectaScrew Extension
K203335
Medacta International S.A.
Orthopedic · 448d
Cleared Jan 31, 2022
MIS Precision Chevron Bunion System
K211628
Relja Innovations, LLC
Orthopedic · 249d
Cleared Jan 18, 2022
JuniOrtho Plating System™
K213572
Orthofix Srl
Orthopedic · 69d
Cleared Jan 14, 2022
BRM TOOL Screws
K203773
Brm Extremities Srl
Orthopedic · 387d
Cleared Jan 11, 2022
Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System
K213199
Stryker GmbH
Orthopedic · 104d
Cleared Jan 04, 2022
DynaFuse Fixation System
K203595
MedShape, Inc.
Orthopedic · 391d
Cleared Dec 30, 2021
Quick-Start Screws
K212547
Innovate Orthopaedics Limited
Orthopedic · 139d
Cleared Dec 25, 2021
R3ACT Stabilization System
K211770
Paragon 28, Inc.
Orthopedic · 200d
Cleared Dec 21, 2021
InCore Subtalar System
K213301
Nextremity Solutions, Inc.
Orthopedic · 81d
Cleared Dec 21, 2021
OSSIOfiber Compression Screw, 3.5mm
K213596
OSSIO , Ltd.
Orthopedic · 39d