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
Aug 08, 2003
BIORCI SCREW
Smith & Nephew, Inc.
Orthopedic
18d
Cleared
Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
Smith & Nephew, Inc.
Orthopedic
29d
Cleared
Jun 26, 2003
RAPIDFIRE SELF DRILLING SCREWS
Walter Lorenz Surgical, Inc.
Orthopedic
21d
Cleared
Jun 19, 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
Inion , Ltd.
Orthopedic
87d
Cleared
Jun 02, 2003
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
Karl Storz Endoscopy
Orthopedic
77d
Cleared
May 30, 2003
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
Inion , Ltd.
Orthopedic
190d
Cleared
Apr 18, 2003
LEFORTE SYSTEM BONE SCREW
Jeil Medical Corporation
Orthopedic
193d
Cleared
Mar 20, 2003
STRYKER BIOZIP SUTURE ANCHOR
Stryker Endoscopy
Orthopedic
176d
Cleared
Mar 20, 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
KARL STORZ Endoscopy-America, Inc.
Orthopedic
44d
Cleared
Mar 20, 2003
EBI DYNAFIX COMPRESSION BONE SCREW
Ebi, L.P.
Orthopedic
14d
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