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
457–480 of 1070
Cleared Sep 10, 2009
UNITY BETA PLLA SYSTEM
K090175
Bonutti Research, Inc.
Orthopedic · 230d
Cleared Sep 02, 2009
MERETE COMPRESSION SCREWS
K091798
Merete Medical GmbH
Orthopedic · 77d
Cleared Jul 31, 2009
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
K090949
Synthes (Usa)
Orthopedic · 119d
Cleared Jul 24, 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
K091577
Extremity Medical, LLC
Orthopedic · 52d
Cleared Jul 15, 2009
TREU
K083912
Treu-Instrumente GmbH
Orthopedic · 197d
Cleared Jul 07, 2009
MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)
K091694
Tag Medical Products
Orthopedic · 27d
Cleared Jun 03, 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Jun 01, 2009
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT
K091069
Medacta International S.A.
Orthopedic · 48d
Cleared May 26, 2009
FUSION MEDICAL CANNULATED SCREW SYSTEM
K081122
John Riccio
Orthopedic · 400d
Cleared May 20, 2009
FUSION MEDICAL STI
K081755
John Riccio
Orthopedic · 334d
Cleared May 06, 2009
LIGAFIX INTERFACE SCREW
K090994
Science For Biomaterials
Orthopedic · 29d
Cleared Apr 23, 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
K082934
Extremity Medical, LLC
Orthopedic · 204d
Cleared Apr 17, 2009
LATARJET CORTICAL SCREW SET
K083096
Tag Medical Products
Orthopedic · 182d
Cleared Mar 25, 2009
WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055
K083792
Medshape Solutions
General & Plastic Surgery · 96d
Cleared Mar 12, 2009
UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM
K081813
U.S. Implant Solutions, LLC
Orthopedic · 259d
Cleared Mar 06, 2009
PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020
K083619
Parcus Medical, LLC
Orthopedic · 88d
Cleared Mar 04, 2009
APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM
K083607
Cayenne Medical, Inc.
Orthopedic · 89d
Cleared Mar 04, 2009
APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM
K083612
Cayenne Medical, Inc.
Orthopedic · 89d
Cleared Feb 05, 2009
BIODRIVE CANNULATED SCREW SYSTEM
K082874
Biomet Trauma
Orthopedic · 129d
Cleared Dec 08, 2008
MAXTORQUE MINI CANNULATED SCREW SYSTEM
K082574
Orthohelix Surgical Designs, Inc.
Orthopedic · 94d
Cleared Nov 25, 2008
POGO SCREW
K080649
Fxdevices
Orthopedic · 263d
Cleared Nov 25, 2008
ORTHOPEDIATRICS BONE SCREWS
K082949
OrthoPediatrics Corp.
Orthopedic · 54d
Cleared Nov 07, 2008
AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45
K081011
Arex USA
Orthopedic · 212d
Cleared Nov 07, 2008
HEALIX TI ANCHOR
K082282
Depuy Mitek, A Johnson & Johnson Co.
Orthopedic · 88d