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
Cleared
Jan 09, 2020
Tyber Medical Trauma Screws
Tyber Medical, LLC
Orthopedic
77d
Cleared
Jan 08, 2020
Tyber Medical Trauma Screw
Tyber Medical, LLC
Orthopedic
76d
Cleared
Dec 31, 2019
InCore TMT System
Nextremity Solutions, Inc.
Orthopedic
103d
Cleared
Nov 26, 2019
ARIX Cannulated Screw System
Jeil Medical Corporation
Orthopedic
83d
Cleared
Nov 26, 2019
DePuy Synthes Trauma Screws
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Orthopedic
57d
Cleared
Nov 06, 2019
Arthrex Nano SwiveLock Suture Anchor
Arthrex, Inc.
Orthopedic
139d
Cleared
Oct 30, 2019
Arthrex Low Profile Screws
Arthrex, Inc.
Orthopedic
204d
Cleared
Oct 16, 2019
SECURE Screw
A.M. Surgical, Inc.
Orthopedic
106d
Cleared
Sep 13, 2019
TDM Screw Systems
Tdm Co., Ltd.
Orthopedic
165d
Cleared
Aug 28, 2019
Interphalangeal Joint Fusion Device Range
Neosteo
Orthopedic
91d
Cleared
Aug 19, 2019
CrossRoads Screw System
Crossroads Extemity Systems, LLC
Orthopedic
91d
Cleared
Aug 13, 2019
PROSTEP™ TBI™ (Tailors Bunion Implant) System
Wrightmedicaltechnologyinc
Orthopedic
123d
Cleared
Jul 29, 2019
Bone Screw Line Addition
Vilex IN Tennessee, Inc.
Orthopedic
77d
Cleared
Jul 26, 2019
ActivOrtho Continuous Compression Screw System
Activortho, Inc.
Orthopedic
21d
Cleared
Jul 05, 2019
OrthoPediatrics Cannulated Screw System
OrthoPediatrics Corp.
Orthopedic
142d
Cleared
Jun 13, 2019
Treace Medical Concepts (TMC) Snap-Off Screw System
Treace Medical Concepts, Inc.
Orthopedic
191d
Cleared
Jun 10, 2019
Mini Cannulated Headed and Headless Screw Set
Stryker GmbH
Orthopedic
214d
Cleared
May 24, 2019
InCore® Lapidus Sterile Kits
Nextremity Solutions, Inc.
Orthopedic
107d
Cleared
May 21, 2019
IntraLock Lapidus System
Fusion Orthopedics, LLC
Orthopedic
266d
Cleared
Apr 17, 2019
Arthrex 2.5 mm Tenodesis Screw
Arthrex, Inc.
Orthopedic
131d
Cleared
Apr 03, 2019
Monster® Screw System
Paragon 28, Inc.
Orthopedic
28d
Cleared
Mar 26, 2019
Arthrex TensionLoc System
Arthrex, Inc.
Orthopedic
90d
Cleared
Mar 22, 2019
OsteoCentric Bone Plate and Screw System
Osteocentric Trauma
Orthopedic
28d
Cleared
Mar 13, 2019
Wright Jones Fracture System
Wrightmedicaltechnologyinc
Orthopedic
132d