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
1070 devices
121–144 of 1070
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
Cleared Dec 16, 2020
CREED™ Cannulated Screws
K200291
Glw Medical, Inc.
Orthopedic · 315d
Cleared Nov 13, 2020
Monster Screw System
K203011
Paragon 28, Inc.
Orthopedic · 43d
Cleared Nov 06, 2020
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
K202589
Medartis AG
General Hospital · 59d
Cleared Oct 22, 2020
GEO Bone Screw System
K202817
Gramercy Extremity Orthopedics, LLC
Orthopedic · 28d
Cleared Oct 15, 2020
OsteoMed ExtremiFix Mini & Small Cannulated Screw System
K202680
Osteomed, LLC
Orthopedic · 30d
Cleared Sep 23, 2020
Responsive Arthroscopy Interference Screw System
K202569
Responsive Arthroscopy, LLC
Orthopedic · 19d
Cleared Sep 22, 2020
LTJ Screws and Washer
K200987
Azurmeds, Inc.
Orthopedic · 160d
Cleared Aug 04, 2020
Vector Hammertoe Correction System
K201850
Nvision Biomedical Technologies, Inc.
Orthopedic · 29d
Cleared Jul 30, 2020
OSSIOfiber™ Compression Screws
K193660
OSSIO , Ltd.
Orthopedic · 213d
Cleared Jul 16, 2020
REDUCT® Headless Compression Screw System
K201662
Skeletal Dynamics, Inc.
Orthopedic · 27d
Cleared Jul 08, 2020
Intraosseous Fixation System
K201556
Extremity Medical, LLC
Orthopedic · 28d
Cleared Jun 26, 2020
RetroFix
K200226
Retrofix Screws, LLC
Orthopedic · 148d
Cleared Jun 26, 2020
DuoHex CH Cannulated Hammertoe System
K200840
Nextremity Solutions, Inc.
Orthopedic · 87d