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
May 11, 2012
HEALIX ADVANCE PEEK ANCHOR
Depuy Mitek
Orthopedic
87d
Cleared
Apr 24, 2012
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
Wrightmedicaltechnologyinc
Orthopedic
53d
Cleared
Apr 10, 2012
SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
Solana Surgical, LLC
Orthopedic
63d
Cleared
Jan 23, 2012
SYNDE-LOCK SYNDESMOSIS REPAIR KIT
Tarsus Medical, Inc.
Orthopedic
196d
Cleared
Jan 13, 2012
MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL
Medical Facets
Orthopedic
115d
Cleared
Jan 04, 2012
DYNA LOCKING CANNULATED SCREW
U&I Corp.
Orthopedic
153d
Cleared
Dec 22, 2011
COLS PEEK
Fournitures Hospitalieres Industrie
Orthopedic
17d
Cleared
Dec 20, 2011
IFS SUBTALAR IMPLANT
Internal Fixation Systems, Inc.
Orthopedic
33d
Cleared
Dec 19, 2011
ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
Ortho Solutions Limited
Orthopedic
264d
Cleared
Dec 19, 2011
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
Zimmer, Inc.
Orthopedic
80d
Cleared
Dec 13, 2011
HEADLESS COMPRESSION SCREW
Skeletal Dynamics, LLC
Orthopedic
90d
Cleared
Dec 12, 2011
OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM
Osteospring Medical, Inc.
Orthopedic
90d
Cleared
Dec 09, 2011
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
Globus Medical, Inc.
Orthopedic
147d
Cleared
Dec 09, 2011
RENOVIS CANNULATED SCREW SYSTEM
Renovis Surgical Technologies, LLC
Orthopedic
52d
Cleared
Dec 06, 2011
DISCO SUBTALAR IMPLANT
Trilliant Surgical, Ltd.
Orthopedic
160d
Cleared
Dec 05, 2011
SYNTHES CORTICAL SCREWS
Synthes USA Products, LLC
Orthopedic
90d
Cleared
Nov 29, 2011
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
Biomet Microfixation, Inc.
Orthopedic
147d
Cleared
Oct 20, 2011
TIGER HEADLESS CANNULATED SCREWS
Trilliant Surgical, Ltd.
Orthopedic
30d
Cleared
Oct 11, 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
Smith & Nephew, Inc.
Orthopedic
90d
Cleared
Oct 07, 2011
ORTHOLOC(TM) BONE SCREWS
Wrightmedicaltechnologyinc
Orthopedic
14d
Cleared
Oct 05, 2011
ZIMMER PERIARTICULAR SCREWS
Zimmer, Inc.
Orthopedic
134d
Cleared
Sep 02, 2011
MICROSUTURE ANCHORS
Arthrex, Inc.
Orthopedic
29d
Cleared
Aug 29, 2011
SLIC SCREW REPAIR SYSTEM
Acumed, LLC
Orthopedic
81d
Cleared
Aug 19, 2011
NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
Ascension Orthopedic
Orthopedic
53d