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
Cleared
Jul 11, 2018
SALVATION Midfoot Nail
Wrightmedicaltechnologyinc
Orthopedic
189d
Cleared
Jun 20, 2018
Fracture and Correction System
In2bones USA, LLC
Orthopedic
128d
Cleared
Jun 04, 2018
VariAx 2 System
Stryker GmbH
Orthopedic
98d
Cleared
May 09, 2018
Diamond Orthopedic Bone Fixation Screws and Pins
Diamond Orthopedic, LLC
Orthopedic
29d
Cleared
Apr 25, 2018
InCore® Lapidus System
Nextremity Solutions, Inc.
Orthopedic
85d
Cleared
Apr 20, 2018
SafetyFix EasyOut System
Safetyfix Medical Technologies, Inc.
Orthopedic
29d
Cleared
Feb 12, 2018
MotoBAND CP Implant System
Crossroads Extremity Systems, LLC
Orthopedic
70d
Cleared
Feb 07, 2018
G-Beam Fusion Beaming System
Orthofix Srl
Orthopedic
153d
Cleared
Jan 12, 2018
HBS2 Headless Bone Screw
Stuckenbrock Medizintechnik GmbH
Orthopedic
224d
Cleared
Dec 22, 2017
Arthrosurface Bone Screws
Arthrosurface, Inc.
Orthopedic
136d
Cleared
Dec 14, 2017
Cannulated Screw Internal Fixation System
Life Spine, Inc.
Orthopedic
59d
Cleared
Nov 28, 2017
PIT’Stop® implant
In2bones Sas
Orthopedic
266d
Cleared
Nov 27, 2017
VariAx 2 System
Stryker GmbH
Orthopedic
59d
Cleared
Oct 25, 2017
Treace Medical Concepts (TMC) Compression Screw System
Treace Medical Concepts, Inc.
Orthopedic
55d
Cleared
Oct 23, 2017
IRENE Cannulated Screw System
Tianjin Zhengtian Medical Instrument Co., Ltd.
Orthopedic
290d
Cleared
Oct 23, 2017
MECRON Cannulated Screw System
Merete GmbH
Orthopedic
91d
Cleared
Oct 02, 2017
Large Screws Range
Newclip Technics
Orthopedic
34d
Cleared
Sep 14, 2017
BePOD® Foot Screws
Fournitures Hospitalieres Industrie
Orthopedic
309d
Cleared
Sep 08, 2017
BePOD® EZ Weil Screws
Fournitures Hospitalieres Industrie
Orthopedic
252d
Cleared
Sep 07, 2017
S4 Screw System™
Subchondral Solutions
Orthopedic
400d
Cleared
Sep 01, 2017
ExsoMed ITN Cannulated Screw System
Exsomed Holdings Company, LLC
Orthopedic
94d
Cleared
Aug 18, 2017
Medline UNITE® Snap-Off Screws
Medline Industries, Inc.
Orthopedic
156d
Cleared
Aug 18, 2017
ExsoMed ArcPhix and ExsoMed ArrowPhix
Exsomed Holding Company, LLC
Orthopedic
98d
Cleared
Aug 11, 2017
TalarLift STS
Fusion Orthopedics, LLC
Orthopedic
162d