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
97–120 of 1070
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
Cleared Dec 09, 2021
Nextra CH Cannulated Hammertoe System
K213530
Nextremity Solutions, Inc.
Orthopedic · 34d
Cleared Nov 19, 2021
Vector® Hammertoe Correction System
K213421
Nvision Biomedical Technologies, Inc.
Orthopedic · 30d
Cleared Nov 16, 2021
Sterile PHALINX Hammertoe System
K212996
Wrightmedicaltechnologyinc
Orthopedic · 57d
Cleared Nov 09, 2021
BESPA Charcot System
K202326
Bespa Global, LLC
Orthopedic · 449d
Cleared Oct 21, 2021
Treace Medical Concepts (TMC) Screw Fixation System
K213036
Treace Medical Concepts, Inc.
Orthopedic · 30d
Cleared Oct 05, 2021
ChM 4.5mm Cortical screws
K210490
Chm Sp. Z O.O.
Orthopedic · 228d
Cleared Sep 23, 2021
Nexta PEEK Hammertoe Correction System
K211996
Nextremity Solutions, Inc.
Orthopedic · 87d
Cleared Aug 25, 2021
Auxein Nailing System
K210792
Auxein Medical Private Limited
Orthopedic · 163d
Cleared Aug 20, 2021
Auxilock Titanium Interference Screw
K203029
Auxein Medical Private Limited
Orthopedic · 322d
Cleared Aug 06, 2021
PAO Cortical Screw
K211435
Medacta International S.A.
Orthopedic · 88d
Cleared Aug 06, 2021
TriMed Threaded Intramedullary Nail System
K211783
TriMed, Inc.
Orthopedic · 58d
Cleared Aug 03, 2021
Cannulated Fasteners and Nuts
K211290
OsteoCentric Technologies
Orthopedic · 97d
Cleared Jul 23, 2021
IntraLock System
K210159
Fusion Orthopedics, LLC
Orthopedic · 183d