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
Nov 05, 2008
DARCO SMALL SCREW
Wrightmedicaltechnologyinc
Orthopedic
84d
Cleared
Oct 30, 2008
UNITY BETA ANCHOR SYSTEM
Bonutti Research, Inc.
Orthopedic
30d
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 20, 2008
JMEA CANNULATED BONE SCREW SYSTEM
Jmea Corporation
Orthopedic
202d
Cleared
Aug 12, 2008
BIOACTIF OSTEOTRANS INTERFENCE SCREW
Takiron Co., Ltd.
Orthopedic
85d
Cleared
Aug 05, 2008
BIOPRO GO-EZ SCREW
Biopro, Inc.
Orthopedic
105d
Cleared
Aug 04, 2008
TIGER CANNULATED SCREW SYSTEM
Trilliant Surgical, Ltd.
Orthopedic
67d
Cleared
Jul 23, 2008
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5
Trauson (Jiangsu) Medical Instrument Co., Ltd.
Orthopedic
258d
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
Cleared
Jul 14, 2008
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR
Conmed Linvatec
Orthopedic
333d
Cleared
Jul 10, 2008
ENSPLINT TM BONE SCREW
Sonoma Orthopedic Products, Inc.
Orthopedic
113d
Cleared
Jul 01, 2008
TLS FIXATION SYSTEM
Fournitures Hospitalieres Industrie
Orthopedic
88d
Cleared
Jun 20, 2008
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
Biocomposites, Ltd.
Orthopedic
30d
Cleared
Jun 18, 2008
BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN
Bioretec, Ltd.
Orthopedic
30d
Cleared
Jun 11, 2008
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
Biomet Manufacturing, Inc.
Orthopedic
149d
Cleared
May 13, 2008
OSTEOTRANS-OT SCREW
Takiron Co., Ltd.
Orthopedic
172d
Cleared
May 01, 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
Synthes (Usa)
Orthopedic
16d
Cleared
Apr 23, 2008
PLLA, HA SCREW
Smith & Nephew Inc., Endoscopy Div.
Orthopedic
72d
Cleared
Apr 23, 2008
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
Synthes (Usa)
Orthopedic
20d
Cleared
Apr 10, 2008
DARCO HEADLESS COMPRESSION SCREW
Wrightmedicaltechnologyinc
Orthopedic
15d
Cleared
Mar 25, 2008
AAP CANNULATED SCREW AND DARCO HEADED SCREW
Aap Implantate AG
Orthopedic
71d