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
Cleared
Jun 20, 2020
InFrame™ Cannulated Fixation System
Exsomed Corp.
Orthopedic
19d
Cleared
Jun 17, 2020
Medline UNITE Jones Fracture Screw System
Medline Industires, Inc.
Orthopedic
30d
Cleared
May 13, 2020
InCore MPJ System
Nextremity Solutions, Inc.
Orthopedic
113d
Cleared
May 05, 2020
Healix Compression Screw System
Nvision Biomedical Technologies, Inc.
Orthopedic
29d
Cleared
May 04, 2020
Headless Compression Screw System
Osteocentric Extremities, LLC
Orthopedic
91d
Cleared
Apr 18, 2020
S4 Screw System
Subchondral Solutions, Inc.
Orthopedic
267d
Cleared
Mar 20, 2020
T2 ICF
Stryker GmbH
Orthopedic
107d
Cleared
Mar 19, 2020
restor3d Metallic Interference Screw
Restor3d
Orthopedic
93d
Cleared
Feb 27, 2020
Omnia Medical Trauma Screws
Omnia Medical, LLC
Orthopedic
206d
Cleared
Feb 24, 2020
Titanium Interference Screws
Biomet, Inc.
Orthopedic
73d
Cleared
Feb 10, 2020
Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
Arthrex, Inc.
Orthopedic
88d
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