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
Cleared
Jan 11, 2010
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
Synthes (Usa)
Orthopedic
111d
Cleared
Dec 16, 2009
FOOT AND HAND MOTION SYSTEM
Newclip Technics
Orthopedic
243d
Cleared
Nov 13, 2009
LEFORTE NEUROSYSTEM BONE SCREW
Jeil Medical Corporation
Orthopedic
157d
Cleared
Nov 05, 2009
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N
Arthrocare Corp.
Orthopedic
113d
Cleared
Nov 05, 2009
ASCENSION CANNULATED SCREW SYSTEM
Ascension Orthopedics, Inc.
Orthopedic
87d
Cleared
Sep 30, 2009
PARCUS PPEK CF INTERFERENCE SCREW
Parcus Medical, LLC
Orthopedic
167d
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
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
Apr 23, 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
Extremity Medical, LLC
Orthopedic
204d
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
Dec 08, 2008
MAXTORQUE MINI CANNULATED SCREW SYSTEM
Orthohelix Surgical Designs, Inc.
Orthopedic
94d
Cleared
Nov 25, 2008
ORTHOPEDIATRICS BONE SCREWS
OrthoPediatrics Corp.
Orthopedic
54d
Cleared
Nov 05, 2008
DARCO SMALL SCREW
Wrightmedicaltechnologyinc
Orthopedic
84d
Cleared
Oct 01, 2008
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
Arthrocare Corp.
Orthopedic
90d
Cleared
Sep 17, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
Smith & Nephew, Inc.
Orthopedic
15d
Cleared
Aug 29, 2008
EXTREMITY MEDICAL COMPRESSION SCREW
Extremity Medical, LLC
Orthopedic
53d
Cleared
Aug 05, 2008
BIOPRO GO-EZ SCREW
Biopro, Inc.
Orthopedic
105d
Cleared
Jul 18, 2008
MERETE 3.0 AND 3.5 MM LOCKING SCREWS
Merete Medical GmbH
Orthopedic
49d
Cleared
Jul 17, 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
Synthes (Usa)
Orthopedic
30d