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
Jul 01, 2002
BIOFASTIN RC THREADED SUTURE ANCHOR
Mitek Worldwide
Orthopedic
24d
Cleared
Jun 26, 2002
DUET SUTURE ANCHOR
Bionx Implants, Ltd.
Orthopedic
169d
Cleared
Jun 26, 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
Biomet, Inc.
Orthopedic
22d
Cleared
Jun 25, 2002
TITANIUM CANNULATED INTERFERENCE SCREW
Future Medical Systems, Inc.
Orthopedic
88d
Cleared
Jun 11, 2002
BIOSCREW XTRALOK
Linvatec Corp.
Orthopedic
265d
Cleared
Jun 06, 2002
HBS HEADLESS BONE SCREW
Millennium Medical Technologies, Inc.
Orthopedic
87d
Cleared
May 06, 2002
PRE-LOADED BIOSTINGER HORNET
Linvatec Corp.
Orthopedic
90d
Cleared
Apr 02, 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
Arthrex, Inc.
Orthopedic
85d
Cleared
Mar 27, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
Triage Medical, Inc.
Orthopedic
86d
Cleared
Mar 26, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050
Triage Medical, Inc.
Orthopedic
90d
Cleared
Mar 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
Smith & Nephew, Inc.
Orthopedic
68d
Cleared
Mar 18, 2002
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09
Vilex, Inc.
Orthopedic
90d
Cleared
Mar 15, 2002
COAPT SYSTMES ENDOTINE DEVICE
Coapt Systems, Inc.
Orthopedic
87d
Cleared
Mar 14, 2002
MITEK BIOCRYL INTERFERENCE SCREWS
Mitek Products
Orthopedic
136d
Cleared
Mar 13, 2002
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
American Medical Systems, Inc.
General & Plastic Surgery
30d
Cleared
Feb 28, 2002
LORENZ SELF DRILLING SCREWS
Walter Lorenz Surgical, Inc.
Orthopedic
90d
Cleared
Feb 26, 2002
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
Karl Storz Endoscopy
Orthopedic
162d
Cleared
Feb 26, 2002
SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE
Unitedstates Surgical
Orthopedic
22d
Cleared
Feb 22, 2002
INION CPS BSSO SCREW
Inion , Ltd.
Dental
28d
Cleared
Feb 13, 2002
AOS CANNULATED BONE SCREW SYSTEM
Advanced Orthopaedic Solutions, Inc.
Orthopedic
55d
Cleared
Jan 18, 2002
PLLA CANNULATED INTERFERENCE SCREW
Future Medical Systems, Inc.
Orthopedic
72d
Cleared
Dec 17, 2001
SELF-COUNTERSINKING BONE SCREW
Biomet Orthopedics, Inc.
Orthopedic
55d
Cleared
Dec 17, 2001
DRG ORTHOHEX SS BONE SCREW
Doctor'S Research Group, Inc.
Orthopedic
33d
Cleared
Dec 17, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
Triad Medical, Inc.
Orthopedic
21d