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
Aug 04, 2000
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
Stryker Endoscopy
Orthopedic
317d
Cleared
Jul 11, 2000
THE KALIX IMPLANT
New Deal, S.A.
Orthopedic
85d
Cleared
Apr 26, 2000
BIOLOK SCREW
Encore Orthopedics, Inc.
Orthopedic
182d
Cleared
Apr 03, 2000
ASNIS III CANNULATED SCREW SYSTEM
Howmedica Osteonics Corp.
Orthopedic
83d
Cleared
Mar 10, 2000
NONLINEAR TAPER LAG SCREW
Theken Surgical
Orthopedic
73d
Cleared
Mar 06, 2000
THE LIGAMENT ANCHOR SOFT SCREW
Corin USA
Orthopedic
89d
Cleared
Feb 25, 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM
Smith & Nephew, Inc.
Orthopedic
74d
Cleared
Feb 04, 2000
I.CO.S SCREW
New Deal, S.A.
Orthopedic
88d
Cleared
Feb 03, 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
Synthes (Usa)
Orthopedic
22d
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