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.
1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
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
Cleared
Apr 05, 2013
MERETEC CS, CORTICAL SCREWS
Merete Medical GmbH
Orthopedic
45d
Cleared
Mar 18, 2013
ACUMED CANNULATED SCREW SYSTEM
Acumed, LLC
Orthopedic
90d
Cleared
Feb 27, 2013
INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
Inion OY
Orthopedic
90d
Cleared
Feb 01, 2013
MILAGRO ADVANCE INTERFERENCE SCREW
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
92d
Cleared
Dec 10, 2012
EMERGE MEDICAL SOLID BONE SCREWS
Emerge Medical
Orthopedic
117d
Cleared
Nov 20, 2012
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
Smith & Nephew, Inc.
Orthopedic
88d
Cleared
Nov 07, 2012
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
Z-Medical GmbH & Co. KG
Orthopedic
194d
Cleared
Nov 07, 2012
GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
Solana Surgical, LLC
Orthopedic
62d
Cleared
Nov 07, 2012
HAMMER TOE IMPLANT
Trilliant Surgical, Ltd.
Orthopedic
43d
Cleared
Oct 09, 2012
NEXTRA TI HAMMERTOE CORRECTION SYSTEM
Nextremity Solutions, LLC
Orthopedic
90d
Cleared
Oct 04, 2012
ACTIVE SCREW BONE SCREW
Intelligent Implant Systems, LLC
Orthopedic
119d
Cleared
Sep 27, 2012
PMT BONE SCREWS
Providence Medical Technology, Inc.
Orthopedic
108d
Cleared
Aug 20, 2012
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D
Medical Design, LLC
Orthopedic
126d
Cleared
Jul 18, 2012
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
Extremity Medical, LLC
Orthopedic
75d
Cleared
Jul 18, 2012
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
Extremity Medical, LLC
Orthopedic
68d
Cleared
Jun 05, 2012
CITIEFFE-TITANIUM CANNULATED SCREW
Citieffe
Orthopedic
202d
Cleared
May 25, 2012
I-FUSE HAMMER TOE SYSTEMS
Orthopro, LLC
Orthopedic
231d
Cleared
May 17, 2012
MINI CANNULATED HEADED AND HEADLESS SCREW SET
Instratek, Inc.
Orthopedic
90d