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
Mar 14, 2008
SUB-TALAR LOK, MODEL 7-11 MM
Instratek, Inc.
Orthopedic
39d
Cleared
Mar 12, 2008
MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
30d
Cleared
Mar 04, 2008
TWINFIX PK FP SUTURE ANCHOR
Smith & Nephew, Inc.
Orthopedic
82d
Cleared
Feb 19, 2008
APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM
Cayenne Medical, Inc.
Orthopedic
76d
Cleared
Dec 10, 2007
TWINFIX FT PK
Smith & Nephew Inc., Endoscopy Division
Orthopedic
70d
Cleared
Dec 04, 2007
MEMOMETAL BONE ANCHORS
Memometal Technologies
Orthopedic
144d
Cleared
Nov 27, 2007
MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER
Cayenne Medical, Inc.
Orthopedic
28d
Cleared
Nov 02, 2007
ACTIVASCREW
Bioretec, Ltd.
Orthopedic
29d
Cleared
Sep 20, 2007
HARPOON SUTURE ANCHOR
Biomet Sports Medicine, Inc.
Orthopedic
80d
Cleared
Sep 17, 2007
STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS
Stryker Endoscopy
Orthopedic
145d
Cleared
Sep 12, 2007
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
KARL STORZ Endoscopy-America, Inc.
Orthopedic
112d
Cleared
Sep 10, 2007
SBI TWISTOFIX
Small Bone Innovations, Inc.
Orthopedic
97d
Cleared
Aug 31, 2007
DOMINATOR
Biocomposites, Ltd.
Orthopedic
29d
Cleared
Aug 29, 2007
SBI FOREFOOT SET
Small Bone Innovations, Inc.
Orthopedic
266d
Cleared
Aug 27, 2007
SBI ARTFIX
Small Bone Innovations, Inc.
Orthopedic
90d
Cleared
Aug 14, 2007
GRAFTLOCK SCREW, ST SCREW
Biocomposites, Ltd.
Orthopedic
29d
Cleared
Aug 13, 2007
IFS BONE FIXATION DEVICES
Internal Fixation Systems, Inc.
Orthopedic
123d
Cleared
Aug 09, 2007
PEEK KNOTLESS ANCHORS
Biomet Sports Medicine, Inc.
Orthopedic
181d
Cleared
Aug 09, 2007
HEALIX ANCHOR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
72d
Cleared
Aug 03, 2007
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
Inion OY
Orthopedic
66d
Cleared
Jul 31, 2007
SUBTALAR IMPLANT
Biomet Sports Medicine, Inc.
Orthopedic
61d
Cleared
Jul 09, 2007
QWIX POSITIONING SCREW
Newdeal Sas
Orthopedic
24d
Cleared
Jun 29, 2007
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW
Arthrex, Inc.
Orthopedic
63d
Cleared
Jun 14, 2007
CANNULATED SCREW
Fournitures Hospitalieres Industrie
Orthopedic
101d