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