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
Cleared
Feb 26, 2003
STRYKER XCEL ANCHOR SYSTEM
Stryker Endoscopy
Orthopedic
169d
Cleared
Feb 06, 2003
KOMPRESSOR SCREW SYSTEM
Kinetikos Medical, Inc.
Orthopedic
45d
Cleared
Jan 09, 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
Biomet Orthopedics, Inc.
Orthopedic
29d
Cleared
Dec 20, 2002
COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
Coapt Systems, Inc.
Orthopedic
25d
Cleared
Dec 20, 2002
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
Howmedica Osteonics Corp.
Orthopedic
11d
Cleared
Dec 09, 2002
AAP CANNULATED SCREWS
Aap Implantate AG
Orthopedic
235d
Cleared
Dec 02, 2002
MODULAR HEAD BONE SCREW
Biomet, Inc.
Orthopedic
88d
Cleared
Oct 18, 2002
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
Osteomed Corp.
Orthopedic
18d
Cleared
Oct 17, 2002
BIOSTEON CROSS PIN
Biocomposites, Ltd.
Orthopedic
171d
Cleared
Oct 09, 2002
BOSWORTH CORACO-CLAVICULAR SCREW
Howmedica Osteonics Corp.
Orthopedic
7d
Cleared
Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
Smith & Nephew, Inc.
Orthopedic
23d
Cleared
Oct 04, 2002
NUGEN FX SCREW
Bionx Implants, Inc.
Orthopedic
23d
Cleared
Oct 03, 2002
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
Arthrex, Inc.
Orthopedic
84d
Cleared
Sep 12, 2002
INION CPS 2.5/2.8 SCREW
Inion , Ltd.
Dental
3d
Cleared
Sep 06, 2002
SYNTHES 6.5 MM CANNULATED SCREW
Synthes (Usa)
Orthopedic
86d
Cleared
Sep 06, 2002
STAYFUSE GT-IP
Pioneer Surgical Technology
Orthopedic
21d
Cleared
Sep 05, 2002
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
Triad Medical, Inc.
Orthopedic
27d
Cleared
Aug 12, 2002
MAGLY 6.5MM CANNULATED SCREWS
Magly Orthopedics, LLC
Orthopedic
84d
Cleared
Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
Synthes (Usa)
Orthopedic
88d
Cleared
Aug 09, 2002
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
Magly Orthopedics, LLC
Orthopedic
87d
Cleared
Jul 29, 2002
WISORB MALLEOLAR SCREW
Cambridge Scientific, Inc.
Orthopedic
188d
Cleared
Jul 17, 2002
LACTOSORB MINI INTERFERENCE SCREW
Biomet Orthopedics, Inc.
Orthopedic
89d
Cleared
Jul 17, 2002
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
Inion , Ltd.
Orthopedic
86d
Cleared
Jul 01, 2002
SMALL HAMMER TOE PIN
Biomet, Inc.
Orthopedic
27d