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).

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
337–360 of 1064
Cleared Feb 28, 2014
FIXOS SCREW SYSTEM
K133451
Stryker Trauma AG
Orthopedic · 108d
Cleared Feb 28, 2014
OSTEOMED EXTREMIFUSE SYSTEM
K140283
Osteomed
Orthopedic · 24d
Cleared Jan 22, 2014
CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM
K130613
Laura Cattabriga
Orthopedic · 321d
Cleared Dec 18, 2013
AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION
K133440
Stryker Trauma AG
Orthopedic · 36d
Cleared Dec 18, 2013
APTUS CANNULATED COMPRESSION SCREWS
K133460
Medartis AG
Orthopedic · 36d
Cleared Dec 16, 2013
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
K132910
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Dec 13, 2013
NORMED PELLEGRIN CALCANEUS STOP SCREW
K133035
Normed Medizin-Technik GmbH
Orthopedic · 77d
Cleared Nov 27, 2013
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
K131591
Pega Medical, Inc.
Orthopedic · 180d
Cleared Nov 25, 2013
ARTHREX COMPRESSION FT SCREWS
K132217
Arthrex, Inc.
Orthopedic · 131d
Cleared Nov 20, 2013
EDGE ORTHOPAEDICS BITE COMPRESSION SCREW
K132893
Icon Orthopaedic Concepts Dba Edge Orthopaedics
Orthopedic · 65d
Cleared Oct 30, 2013
FLOWER BONE SCREW SET
K132248
Flower Orthopedics Corporation
Orthopedic · 103d
Cleared Sep 19, 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810
Zimmer, Inc.
Orthopedic · 178d
Cleared Aug 28, 2013
SELF-COMPRESSIVE SCREW
K131471
Neosteo
Orthopedic · 98d
Cleared Aug 21, 2013
SWING-OFF SCREW
K130627
Advanced Interventional Technology, LLC
Orthopedic · 166d
Cleared Jul 26, 2013
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
K131264
Gebr. Brasseler GmbH & Co. KG
Orthopedic · 84d
Cleared Jul 25, 2013
HAMMERTOE CORRECTION SYSTEM
K130859
Arthrosurface, Inc.
Orthopedic · 119d
Cleared Jul 25, 2013
JONES-FX FRACTURE SYSTEM
K131620
Instratek, Inc.
Orthopedic · 52d
Cleared May 31, 2013
MEDLINE CANNULATED SCREW
K130319
Medline Industries, Inc.
Orthopedic · 112d
Cleared May 31, 2013
OSTEOMED EXTREMIFUSE SYSTEM
K130412
Osteomed
Orthopedic · 101d
Cleared May 31, 2013
ARS SCREW
K130954
Advanced Interventional Technology, LLC
Orthopedic · 56d
Cleared May 31, 2013
MAXTORQUE SCREW SYSTEM
K131324
Orthohelix Surgical Designs, Inc.
Orthopedic · 23d
Cleared Apr 22, 2013
AAP CANNULATED SCREW 2.0
K130590
Aap Implantate AG
Orthopedic · 46d
Cleared Apr 11, 2013
EXTREMITY MEDICAL IP FUSION SYSTEM
K130120
Extremity Medical, LLC
Orthopedic · 84d
Cleared Apr 05, 2013
MONSTER SCREW SYSTEM
K124027
Apogee Orthosolutions
Orthopedic · 98d