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
625–648 of 1064
Cleared Aug 08, 2003
BIORCI SCREW
K032224
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Jun 26, 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Jun 19, 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K030900
Inion , Ltd.
Orthopedic · 87d
Cleared Jun 02, 2003
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K030848
Karl Storz Endoscopy
Orthopedic · 77d
Cleared May 30, 2003
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K023887
Inion , Ltd.
Orthopedic · 190d
Cleared Apr 18, 2003
LEFORTE SYSTEM BONE SCREW
K023365
Jeil Medical Corporation
Orthopedic · 193d
Cleared Mar 20, 2003
STRYKER BIOZIP SUTURE ANCHOR
K023192
Stryker Endoscopy
Orthopedic · 176d
Cleared Mar 20, 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 44d
Cleared Mar 20, 2003
EBI DYNAFIX COMPRESSION BONE SCREW
K030706
Ebi, L.P.
Orthopedic · 14d
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