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
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
Cleared
Aug 09, 2011
METASURG SUBTALAR IMPLANT
Metasurg
Orthopedic
97d
Cleared
Jul 28, 2011
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
Parcus Medical, LLC
Orthopedic
108d
Cleared
Jul 25, 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
Synthes (Usa)
Orthopedic
145d
Cleared
Jul 21, 2011
METASURG DIGIFUSE IMPLANT
Metasurg
Orthopedic
49d
Cleared
Jul 20, 2011
AAP CANNULATED SCREWS
Aap Implantate AG
Orthopedic
71d
Cleared
Jul 12, 2011
PRO FIXATION SYSTEM
Synovis Orthopedic & Woundcare
Orthopedic
137d