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).

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
121–144 of 1064
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
Cleared Jun 20, 2020
InFrame™ Cannulated Fixation System
K201430
Exsomed Corp.
Orthopedic · 19d
Cleared Jun 17, 2020
Medline UNITE Jones Fracture Screw System
K201319
Medline Industires, Inc.
Orthopedic · 30d
Cleared May 13, 2020
InCore MPJ System
K200124
Nextremity Solutions, Inc.
Orthopedic · 113d
Cleared May 05, 2020
Healix Compression Screw System
K200914
Nvision Biomedical Technologies, Inc.
Orthopedic · 29d
Cleared May 04, 2020
Headless Compression Screw System
K200259
Osteocentric Extremities, LLC
Orthopedic · 91d
Cleared Apr 18, 2020
S4 Screw System
K191995
Subchondral Solutions, Inc.
Orthopedic · 267d