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).

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
697–720 of 1070
Cleared Feb 26, 2003
STRYKER XCEL ANCHOR SYSTEM
K023013
Stryker Endoscopy
Orthopedic · 169d
Cleared Feb 06, 2003
KOMPRESSOR SCREW SYSTEM
K024233
Kinetikos Medical, Inc.
Orthopedic · 45d
Cleared Jan 09, 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K024086
Biomet Orthopedics, Inc.
Orthopedic · 29d
Cleared Dec 20, 2002
COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
K023922
Coapt Systems, Inc.
Orthopedic · 25d
Cleared Dec 20, 2002
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060
Howmedica Osteonics Corp.
Orthopedic · 11d
Cleared Dec 09, 2002
AAP CANNULATED SCREWS
K021233
Aap Implantate AG
Orthopedic · 235d
Cleared Dec 02, 2002
MODULAR HEAD BONE SCREW
K022952
Biomet, Inc.
Orthopedic · 88d
Cleared Oct 18, 2002
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
K023260
Osteomed Corp.
Orthopedic · 18d
Cleared Oct 17, 2002
BIOSTEON CROSS PIN
K021351
Biocomposites, Ltd.
Orthopedic · 171d
Cleared Oct 09, 2002
BOSWORTH CORACO-CLAVICULAR SCREW
K023294
Howmedica Osteonics Corp.
Orthopedic · 7d
Cleared Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Oct 04, 2002
NUGEN FX SCREW
K023022
Bionx Implants, Inc.
Orthopedic · 23d
Cleared Oct 03, 2002
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
K022234
Arthrex, Inc.
Orthopedic · 84d
Cleared Sep 12, 2002
INION CPS 2.5/2.8 SCREW
K022981
Inion , Ltd.
Dental · 3d
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 Sep 05, 2002
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
K022647
Triad Medical, Inc.
Orthopedic · 27d
Cleared Aug 12, 2002
MAGLY 6.5MM CANNULATED SCREWS
K021662
Magly Orthopedics, LLC
Orthopedic · 84d
Cleared Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556
Synthes (Usa)
Orthopedic · 88d
Cleared Aug 09, 2002
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
K021579
Magly Orthopedics, LLC
Orthopedic · 87d
Cleared Jul 29, 2002
WISORB MALLEOLAR SCREW
K020222
Cambridge Scientific, Inc.
Orthopedic · 188d
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