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
481–504 of 1070
Cleared Nov 05, 2008
DARCO SMALL SCREW
K082320
Wrightmedicaltechnologyinc
Orthopedic · 84d
Cleared Oct 30, 2008
UNITY BETA ANCHOR SYSTEM
K082906
Bonutti Research, Inc.
Orthopedic · 30d
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 20, 2008
JMEA CANNULATED BONE SCREW SYSTEM
K080259
Jmea Corporation
Orthopedic · 202d
Cleared Aug 12, 2008
BIOACTIF OSTEOTRANS INTERFENCE SCREW
K081390
Takiron Co., Ltd.
Orthopedic · 85d
Cleared Aug 05, 2008
BIOPRO GO-EZ SCREW
K081149
Biopro, Inc.
Orthopedic · 105d
Cleared Aug 04, 2008
TIGER CANNULATED SCREW SYSTEM
K081510
Trilliant Surgical, Ltd.
Orthopedic · 67d
Cleared Jul 23, 2008
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5
K073159
Trauson (Jiangsu) Medical Instrument Co., Ltd.
Orthopedic · 258d
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
Cleared Jul 14, 2008
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR
K072291
Conmed Linvatec
Orthopedic · 333d
Cleared Jul 10, 2008
ENSPLINT TM BONE SCREW
K080778
Sonoma Orthopedic Products, Inc.
Orthopedic · 113d
Cleared Jul 01, 2008
TLS FIXATION SYSTEM
K080974
Fournitures Hospitalieres Industrie
Orthopedic · 88d
Cleared Jun 20, 2008
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
K081428
Biocomposites, Ltd.
Orthopedic · 30d
Cleared Jun 18, 2008
BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN
K081392
Bioretec, Ltd.
Orthopedic · 30d
Cleared Jun 11, 2008
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
K080088
Biomet Manufacturing, Inc.
Orthopedic · 149d
Cleared May 13, 2008
OSTEOTRANS-OT SCREW
K073312
Takiron Co., Ltd.
Orthopedic · 172d
Cleared May 01, 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
K081071
Synthes (Usa)
Orthopedic · 16d
Cleared Apr 23, 2008
PLLA, HA SCREW
K080358
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 72d
Cleared Apr 23, 2008
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
K080943
Synthes (Usa)
Orthopedic · 20d
Cleared Apr 10, 2008
DARCO HEADLESS COMPRESSION SCREW
K080850
Wrightmedicaltechnologyinc
Orthopedic · 15d
Cleared Mar 25, 2008
AAP CANNULATED SCREW AND DARCO HEADED SCREW
K080101
Aap Implantate AG
Orthopedic · 71d