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
97–120 of 1059
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
Cleared Jul 22, 2021
Medline UNITE® Digital Fusion Screw System
K211944
Medline Industries, Inc.
Orthopedic · 29d
Cleared Jun 01, 2021
Arthrex Beveled FT Screws
K210994
Arthrex, Inc.
Orthopedic · 60d
Cleared May 28, 2021
Axis Charcot Fixation System
K211261
Extremity Medical, LLC
Orthopedic · 32d
Cleared May 11, 2021
DART-FIRE EDGE Cannulated Screw System
K203228
Wright Medical
Orthopedic · 190d
Cleared Apr 14, 2021
Cannulated Fasteners and Nuts
K210754
OsteoCentric Technologies
Orthopedic · 30d
Cleared Feb 26, 2021
LTJ Screws and Washer
K210268
Azurmeds, Inc.
Orthopedic · 25d
Cleared Jan 15, 2021
Dynanail Mini Hybrid
K203381
MedShape, Inc.
Orthopedic · 59d
Cleared Jan 13, 2021
Inion CompressOn Screw
K203105
Inion OY
Orthopedic · 90d
Cleared Jan 05, 2021
Fixone Biocomposite Interference Screw
K193497
Aju Pharm Co., Ltd.
Orthopedic · 385d
Cleared Dec 30, 2020
Arthrex Low Profile Screws
K203239
Arthrex, Inc.
Orthopedic · 57d
Cleared Dec 23, 2020
WishBone Medical Plate and Screw System
K203467
Wishbone Medical, Inc.
Orthopedic · 28d