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
Mar 08, 2017
OrthoSolutions 'System26' Bone Screws
Ortho Solutions UK Limited
Orthopedic
86d
Cleared
Mar 03, 2017
ToeMATE® Hammertoe Correction System
Arthrosurface, Inc.
Orthopedic
28d
Cleared
Feb 28, 2017
EPIC Extremity Snap-Off Screw
Epic Extremity, LLC
Orthopedic
120d
Cleared
Feb 21, 2017
SurgTech Trauma System
Surgtech, Inc.
Orthopedic
225d
Cleared
Feb 16, 2017
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
Synthes USA Products, LLC
Orthopedic
248d
Cleared
Feb 09, 2017
RASL Repair Kit
Radicle Orthopaedics, Inc.
Orthopedic
273d
Cleared
Jan 18, 2017
GEO Bone Screw System
Gramercy Extremity Orthopeidics, LLC
Orthopedic
191d
Cleared
Dec 19, 2016
KLS Martin Cannulated Headless Screws
KLS-Martin L.P.
Orthopedic
229d
Cleared
Dec 05, 2016
4.0 and 6.5 Cancellous Bone Screw and Washer
Smv Scientific
Orthopedic
244d
Cleared
Nov 22, 2016
ToeTac™ 10° Hammertoe Fixation System
Restore Surgical, LLC Dba Instratek
Orthopedic
146d
Cleared
Nov 16, 2016
Tyber Medical BioTy® Nanotopography Trauma Screw
Tyber Medical, LLC
Orthopedic
160d
Cleared
Nov 15, 2016
AmorChem Titanium Porous Fixation Device
Amorchem Holdings, Inc.
Orthopedic
237d
Cleared
Oct 11, 2016
HammerTech Fixation System
Fusion Orthopedics, LLC
Orthopedic
139d
Cleared
Oct 06, 2016
I.B.S. 2.0 Osteosynthesis screw
In2bones Sas
Orthopedic
253d
Cleared
Aug 01, 2016
The Hammertoe Correction System
Life Spine, Inc.
Orthopedic
284d
Cleared
Jul 29, 2016
Cannulated Screw
Miami Device Solutions, LLC
Orthopedic
105d
Cleared
Jun 30, 2016
Arthrosurface Bone Screws
Arthrosurface, Inc.
Orthopedic
27d
Cleared
Jun 23, 2016
The Life Spine Subtalar Implant System
Life Spine
Orthopedic
148d
Cleared
Jun 03, 2016
dynaMX(TM) Nitinol Compression Screw
Mx Orthopedics, Corp.
Orthopedic
108d
Cleared
Jun 03, 2016
Large Screws Range
Newclip Technics
Orthopedic
92d
Cleared
Apr 29, 2016
OsteoBullet Compression Screw
Phalanx Innovations
Orthopedic
85d
Cleared
Apr 29, 2016
MC-Subtalar(TM) II
Merete Medical GmbH
Orthopedic
60d
Cleared
Apr 19, 2016
Bicortical Fixation Screw & Washer Nut System
First Ray, LLC
Orthopedic
123d
Cleared
Mar 28, 2016
SMV Scientific Schanz Screws
Smv Scientific
Orthopedic
26d