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).

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
241–264 of 1070
Cleared Mar 08, 2017
OrthoSolutions 'System26' Bone Screws
K163489
Ortho Solutions UK Limited
Orthopedic · 86d
Cleared Mar 03, 2017
ToeMATE® Hammertoe Correction System
K170350
Arthrosurface, Inc.
Orthopedic · 28d
Cleared Feb 28, 2017
EPIC Extremity Snap-Off Screw
K163038
Epic Extremity, LLC
Orthopedic · 120d
Cleared Feb 21, 2017
SurgTech Trauma System
K161894
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
K161616
Synthes USA Products, LLC
Orthopedic · 248d
Cleared Feb 09, 2017
RASL Repair Kit
K161334
Radicle Orthopaedics, Inc.
Orthopedic · 273d
Cleared Jan 18, 2017
GEO Bone Screw System
K161904
Gramercy Extremity Orthopeidics, LLC
Orthopedic · 191d
Cleared Dec 19, 2016
KLS Martin Cannulated Headless Screws
K161259
KLS-Martin L.P.
Orthopedic · 229d
Cleared Dec 05, 2016
4.0 and 6.5 Cancellous Bone Screw and Washer
K160946
Smv Scientific
Orthopedic · 244d
Cleared Nov 22, 2016
ToeTac™ 10° Hammertoe Fixation System
K161778
Restore Surgical, LLC Dba Instratek
Orthopedic · 146d
Cleared Nov 16, 2016
Tyber Medical BioTy® Nanotopography Trauma Screw
K161597
Tyber Medical, LLC
Orthopedic · 160d
Cleared Nov 15, 2016
AmorChem Titanium Porous Fixation Device
K160791
Amorchem Holdings, Inc.
Orthopedic · 237d
Cleared Oct 11, 2016
HammerTech Fixation System
K161449
Fusion Orthopedics, LLC
Orthopedic · 139d
Cleared Oct 06, 2016
I.B.S. 2.0 Osteosynthesis screw
K160174
In2bones Sas
Orthopedic · 253d
Cleared Aug 01, 2016
The Hammertoe Correction System
K153065
Life Spine, Inc.
Orthopedic · 284d
Cleared Jul 29, 2016
Cannulated Screw
K161058
Miami Device Solutions, LLC
Orthopedic · 105d
Cleared Jun 30, 2016
Arthrosurface Bone Screws
K161539
Arthrosurface, Inc.
Orthopedic · 27d
Cleared Jun 23, 2016
The Life Spine Subtalar Implant System
K160169
Life Spine
Orthopedic · 148d
Cleared Jun 03, 2016
dynaMX(TM) Nitinol Compression Screw
K160427
Mx Orthopedics, Corp.
Orthopedic · 108d
Cleared Jun 03, 2016
Large Screws Range
K160617
Newclip Technics
Orthopedic · 92d
Cleared Apr 29, 2016
OsteoBullet Compression Screw
K160304
Phalanx Innovations
Orthopedic · 85d
Cleared Apr 29, 2016
MC-Subtalar(TM) II
K160548
Merete Medical GmbH
Orthopedic · 60d
Cleared Apr 19, 2016
Bicortical Fixation Screw & Washer Nut System
K153638
First Ray, LLC
Orthopedic · 123d
Cleared Mar 28, 2016
SMV Scientific Schanz Screws
K160603
Smv Scientific
Orthopedic · 26d