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
289–312 of 1070
Cleared Jul 15, 2015
OsteoMed Cannulated Screw System
K151021
Osteomed Corp.
Orthopedic · 90d
Cleared Jul 15, 2015
Monster Screw System
K151418
Paragon 28
Orthopedic · 48d
Cleared Jun 23, 2015
SMV Scientific Bone Screws
K150981
Smv Scientific
Orthopedic · 70d
Cleared Jun 12, 2015
Sonoma Cancellous Bone Screw and Washer
K150376
Sonoma Orthopedics Products, Inc.
Orthopedic · 119d
Cleared Jun 04, 2015
ToeTac Hammertoe Fixation System
K150443
Restore Surgical, LLC Dba Instratek
Orthopedic · 104d
Cleared May 26, 2015
Biomet Microfixation RibFix Blu Thoracic Fixation System
K151173
Biomet Microfixation
Orthopedic · 25d
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