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