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
145–168 of 1064
Cleared Mar 20, 2020
T2 ICF
K193366
Stryker GmbH
Orthopedic · 107d
Cleared Mar 19, 2020
restor3d Metallic Interference Screw
K193491
Restor3d
Orthopedic · 93d
Cleared Feb 27, 2020
Omnia Medical Trauma Screws
K192096
Omnia Medical, LLC
Orthopedic · 206d
Cleared Feb 24, 2020
Titanium Interference Screws
K193451
Biomet, Inc.
Orthopedic · 73d
Cleared Feb 10, 2020
Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
K193156
Arthrex, Inc.
Orthopedic · 88d
Cleared Jan 09, 2020
Tyber Medical Trauma Screws
K192975
Tyber Medical, LLC
Orthopedic · 77d
Cleared Jan 08, 2020
Tyber Medical Trauma Screw
K192974
Tyber Medical, LLC
Orthopedic · 76d
Cleared Dec 31, 2019
InCore TMT System
K192578
Nextremity Solutions, Inc.
Orthopedic · 103d
Cleared Nov 26, 2019
ARIX Cannulated Screw System
K192417
Jeil Medical Corporation
Orthopedic · 83d
Cleared Nov 26, 2019
DePuy Synthes Trauma Screws
K192745
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Orthopedic · 57d
Cleared Nov 06, 2019
Arthrex Nano SwiveLock Suture Anchor
K191651
Arthrex, Inc.
Orthopedic · 139d
Cleared Oct 30, 2019
Arthrex Low Profile Screws
K190921
Arthrex, Inc.
Orthopedic · 204d
Cleared Oct 16, 2019
SECURE Screw
K191771
A.M. Surgical, Inc.
Orthopedic · 106d
Cleared Sep 13, 2019
TDM Screw Systems
K190830
Tdm Co., Ltd.
Orthopedic · 165d
Cleared Aug 28, 2019
Interphalangeal Joint Fusion Device Range
K191424
Neosteo
Orthopedic · 91d
Cleared Aug 19, 2019
CrossRoads Screw System
K191342
Crossroads Extemity Systems, LLC
Orthopedic · 91d
Cleared Aug 13, 2019
PROSTEP™ TBI™ (Tailors Bunion Implant) System
K190970
Wrightmedicaltechnologyinc
Orthopedic · 123d
Cleared Jul 29, 2019
Bone Screw Line Addition
K191289
Vilex IN Tennessee, Inc.
Orthopedic · 77d
Cleared Jul 26, 2019
ActivOrtho Continuous Compression Screw System
K191817
Activortho, Inc.
Orthopedic · 21d
Cleared Jul 05, 2019
OrthoPediatrics Cannulated Screw System
K190324
OrthoPediatrics Corp.
Orthopedic · 142d
Cleared Jun 13, 2019
Treace Medical Concepts (TMC) Snap-Off Screw System
K183363
Treace Medical Concepts, Inc.
Orthopedic · 191d
Cleared Jun 10, 2019
Mini Cannulated Headed and Headless Screw Set
K183104
Stryker GmbH
Orthopedic · 214d
Cleared May 24, 2019
InCore® Lapidus Sterile Kits
K190231
Nextremity Solutions, Inc.
Orthopedic · 107d
Cleared May 21, 2019
IntraLock Lapidus System
K182342
Fusion Orthopedics, LLC
Orthopedic · 266d