HWC · Class II · 21 CFR 888.3040

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
649–672 of 1064
Cleared Sep 06, 2002
SYNTHES 6.5 MM CANNULATED SCREW
K021932
Synthes (Usa)
Orthopedic · 86d
Cleared Sep 06, 2002
STAYFUSE GT-IP
K022726
Pioneer Surgical Technology
Orthopedic · 21d
Cleared Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556
Synthes (Usa)
Orthopedic · 88d
Cleared Jul 17, 2002
LACTOSORB MINI INTERFERENCE SCREW
K021254
Biomet Orthopedics, Inc.
Orthopedic · 89d
Cleared Jul 17, 2002
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K021280
Inion , Ltd.
Orthopedic · 86d
Cleared Jul 01, 2002
SMALL HAMMER TOE PIN
K021828
Biomet, Inc.
Orthopedic · 27d
Cleared Jun 26, 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832
Biomet, Inc.
Orthopedic · 22d
Cleared Jun 11, 2002
BIOSCREW XTRALOK
K013131
Linvatec Corp.
Orthopedic · 265d
Cleared May 06, 2002
PRE-LOADED BIOSTINGER HORNET
K020377
Linvatec Corp.
Orthopedic · 90d
Cleared Apr 02, 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043
Arthrex, Inc.
Orthopedic · 85d
Cleared Mar 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Mar 15, 2002
COAPT SYSTMES ENDOTINE DEVICE
K014153
Coapt Systems, Inc.
Orthopedic · 87d
Cleared Mar 14, 2002
MITEK BIOCRYL INTERFERENCE SCREWS
K013572
Mitek Products
Orthopedic · 136d
Cleared Mar 13, 2002
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K020446
American Medical Systems, Inc.
General & Plastic Surgery · 30d
Cleared Feb 28, 2002
LORENZ SELF DRILLING SCREWS
K013954
Walter Lorenz Surgical, Inc.
Orthopedic · 90d
Cleared Feb 26, 2002
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K013107
Karl Storz Endoscopy
Orthopedic · 162d
Cleared Feb 22, 2002
INION CPS BSSO SCREW
K020266
Inion , Ltd.
Dental · 28d
Cleared Feb 13, 2002
AOS CANNULATED BONE SCREW SYSTEM
K014185
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 55d
Cleared Dec 17, 2001
SELF-COUNTERSINKING BONE SCREW
K013534
Biomet Orthopedics, Inc.
Orthopedic · 55d
Cleared Dec 11, 2001
SURGICAL DYNAMICS MENISCAL STAPLE
K013890
United States Surgical, A Division of Tyco Healthc
Orthopedic · 18d
Cleared Dec 10, 2001
REUNITE FUSION SCREW
K011451
Biomet, Inc.
Orthopedic · 213d
Cleared Dec 03, 2001
RESORBABLE NO PROFILE SCREW AND WASHER
K012469
Biomet Manufacturing, Inc.
Orthopedic · 123d
Cleared Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
K012572
Biomet, Inc.
Orthopedic · 116d
Cleared Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945
Synthes (Usa)
Orthopedic · 90d