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
433–456 of 1064
Cleared Jan 11, 2010
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
K092909
Synthes (Usa)
Orthopedic · 111d
Cleared Dec 16, 2009
FOOT AND HAND MOTION SYSTEM
K091118
Newclip Technics
Orthopedic · 243d
Cleared Nov 13, 2009
LEFORTE NEUROSYSTEM BONE SCREW
K091686
Jeil Medical Corporation
Orthopedic · 157d
Cleared Nov 05, 2009
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N
K092133
Arthrocare Corp.
Orthopedic · 113d
Cleared Nov 05, 2009
ASCENSION CANNULATED SCREW SYSTEM
K092440
Ascension Orthopedics, Inc.
Orthopedic · 87d
Cleared Sep 30, 2009
PARCUS PPEK CF INTERFERENCE SCREW
K091093
Parcus Medical, LLC
Orthopedic · 167d
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 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 Apr 23, 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
K082934
Extremity Medical, LLC
Orthopedic · 204d
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 Dec 08, 2008
MAXTORQUE MINI CANNULATED SCREW SYSTEM
K082574
Orthohelix Surgical Designs, Inc.
Orthopedic · 94d
Cleared Nov 25, 2008
ORTHOPEDIATRICS BONE SCREWS
K082949
OrthoPediatrics Corp.
Orthopedic · 54d
Cleared Nov 05, 2008
DARCO SMALL SCREW
K082320
Wrightmedicaltechnologyinc
Orthopedic · 84d
Cleared Oct 01, 2008
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
K081893
Arthrocare Corp.
Orthopedic · 90d
Cleared Sep 17, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Aug 29, 2008
EXTREMITY MEDICAL COMPRESSION SCREW
K081934
Extremity Medical, LLC
Orthopedic · 53d
Cleared Aug 05, 2008
BIOPRO GO-EZ SCREW
K081149
Biopro, Inc.
Orthopedic · 105d
Cleared Jul 18, 2008
MERETE 3.0 AND 3.5 MM LOCKING SCREWS
K081513
Merete Medical GmbH
Orthopedic · 49d
Cleared Jul 17, 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700
Synthes (Usa)
Orthopedic · 30d