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
Jan 12, 2000
BIORCI SCREW
Smith & Nephew Endoscopy, Inc.
Orthopedic
177d
Cleared
Dec 20, 1999
EIS THREADED SCREW FRACTURE FIXATION
Groupe Lepine
Orthopedic
193d
Cleared
Dec 20, 1999
ABSOLUTE ABSORBABLE INTERFERENCE SCREW
Innovasive Devices, Inc.
Orthopedic
26d
Cleared
Nov 18, 1999
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
Smith & Nephew, Inc.
Orthopedic
78d
Cleared
Nov 16, 1999
BONE BULLET SUTURE ANCHOR
Linvatec Corp.
Orthopedic
232d
Cleared
Oct 08, 1999
MODIFICATION TO BONE MULCH SCREW SYSTEM
Biomet, Inc.
Orthopedic
29d
Cleared
Sep 23, 1999
EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS
Electro-Biology, Inc.
Orthopedic
70d
Cleared
Sep 22, 1999
MITEK ROTATOR CUFF QUICKANCHOR PLUS
Mitek Products
Orthopedic
49d
Cleared
Sep 21, 1999
MITEK MINI QUICKANCHOR PLUS
Mitek Products
Orthopedic
57d
Cleared
Sep 21, 1999
CANNULATED SMARTSCREW MODELS 224540C, 224570C
Bionx Implants, Ltd.
Orthopedic
20d
Cleared
Sep 17, 1999
BIOBUTTON
Linvatec Corp.
Orthopedic
239d
Cleared
Sep 17, 1999
MODUS SYSTEM SELF-DRILLING SCREWS
Medartis AG
Orthopedic
87d
Cleared
Sep 01, 1999
REUNITE SCREWS
Biomet Manufacturing, Inc.
Orthopedic
55d
Cleared
Jul 30, 1999
BIORC ANCHOR
Linvatec Corp.
Orthopedic
143d
Cleared
Jul 30, 1999
STAPLETAC BONE ANCHOR SYSTEM
Influence, Inc.
Orthopedic
23d
Cleared
Jul 14, 1999
SPIN SNAP-OFF SCREW
New Deal, S.A.
Orthopedic
77d
Cleared
Jul 01, 1999
BIO-INTERFERENCE SCREW
Innovasive Devices, Inc.
Orthopedic
139d
Cleared
Jun 01, 1999
BONE SCREWS
Bregma International Trading Company , Ltd.
Orthopedic
116d
Cleared
May 14, 1999
BONE MULCH SCREW SYSTEM
Biomet, Inc.
Orthopedic
29d
Cleared
Apr 29, 1999
BOLD SCREW
New Deal, S.A.
Orthopedic
63d
Cleared
Apr 29, 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
Aap Implantate AG
Orthopedic
51d
Cleared
Apr 29, 1999
STAYFUSE
Pioneer Surgical Technology
Orthopedic
50d
Cleared
Apr 26, 1999
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW
Vilex, Inc.
Orthopedic
20d
Cleared
Apr 26, 1999
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24
Vilex, Inc.
Orthopedic
19d