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., Synthes (Usa) and Wrightmedicaltechnologyinc.

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
289–312 of 1064
Cleared May 15, 2015
Arthrex RetroFusion Screw
K151078
Arthrex, Inc.
Orthopedic · 23d
Cleared May 11, 2015
Life Spine Cannulated Screws
K150126
Life Spine, Inc.
Orthopedic · 111d
Cleared May 08, 2015
Subtalar Spacer System (STS)
K150213
Wrightmedicaltechnologyinc
Orthopedic · 98d
Cleared May 08, 2015
Snap-Off Self-Compressive Screw
K150772
Neosteo
Orthopedic · 45d
Cleared Apr 29, 2015
SMV Scientific 4.5 mm Bone Screws
K150188
Summit Medventures
Orthopedic · 92d
Cleared Apr 29, 2015
PHALINX Hammertoe System
K150252
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Apr 29, 2015
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium
K150974
Aap Implantate AG
Orthopedic · 16d
Cleared Mar 31, 2015
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
K143165
Zimmer, Inc.
Orthopedic · 148d
Cleared Mar 23, 2015
Flow-Screw
K142776
Flow-Fx, LLC
Orthopedic · 178d
Cleared Mar 04, 2015
Extremity Medical Calcaneal Osteotomy Device
K150309
Extremity Medical, LLC
Orthopedic · 23d
Cleared Feb 20, 2015
EASY OUT
K141401
Feet For Life Podiatry Center
Orthopedic · 268d
Cleared Feb 06, 2015
Nexis osteosynthesis snap-off screws
K143146
Novastep
Orthopedic · 95d
Cleared Feb 06, 2015
Nexis osteosynthesis compressive screws
K143229
Novastep
Orthopedic · 88d
Cleared Feb 04, 2015
Extremity Medical Calcaneal Osteotomy Device
K143402
Extremity Medical, LLC
Orthopedic · 68d
Cleared Jan 23, 2015
Cannulated Screw System
K143460
Wrightmedicaltechnologyinc
Orthopedic · 50d
Cleared Jan 16, 2015
CrossRoads Screw System
K143039
Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem
Orthopedic · 86d
Cleared Jan 16, 2015
Arthrex Low Profile Screws
K143614
Arthrex, Inc.
Orthopedic · 28d
Cleared Jan 13, 2015
INFIX CANNULATED SCREW SYSTEM
K142057
Infix Medical, LLC
Orthopedic · 168d
Cleared Jan 13, 2015
Headless Compression Screw System
K143624
Skeletal Dynamics, LLC
Orthopedic · 22d
Cleared Jan 08, 2015
CrossTie Intraosseous Fixation System
K141857
Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem
Orthopedic · 182d
Cleared Dec 30, 2014
3.Omm Biomet Cannulated Screw System
K143188
Biomet Manufacturing Corp
Orthopedic · 55d
Cleared Dec 22, 2014
AnthroBridge-Screw 25,30,35,40,45,50mm
K142528
Agent Medical, LLC
Orthopedic · 104d
Cleared Dec 19, 2014
AIS Odontoid Fracture Fixation System
K142707
Aesculap Implant System, Inc.
Orthopedic · 88d
Cleared Dec 15, 2014
ProxiFuse Hammer Toe Device
K142490
Cartiva, Inc.
Orthopedic · 102d