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
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
Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
Synthes (Usa)
Orthopedic
88d
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
Cleared
Jun 26, 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
Biomet, Inc.
Orthopedic
22d
Cleared
Jun 11, 2002
BIOSCREW XTRALOK
Linvatec Corp.
Orthopedic
265d
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 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
Smith & Nephew, Inc.
Orthopedic
68d
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 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
Dec 17, 2001
SELF-COUNTERSINKING BONE SCREW
Biomet Orthopedics, Inc.
Orthopedic
55d
Cleared
Dec 11, 2001
SURGICAL DYNAMICS MENISCAL STAPLE
United States Surgical, A Division of Tyco Healthc
Orthopedic
18d
Cleared
Dec 10, 2001
REUNITE FUSION SCREW
Biomet, Inc.
Orthopedic
213d
Cleared
Dec 03, 2001
RESORBABLE NO PROFILE SCREW AND WASHER
Biomet Manufacturing, Inc.
Orthopedic
123d
Cleared
Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
Biomet, Inc.
Orthopedic
116d
Cleared
Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
Synthes (Usa)
Orthopedic
90d