HWC · Class II · 21 CFR 888.3040

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
697–720 of 1064
Cleared Aug 04, 2000
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K993166
Stryker Endoscopy
Orthopedic · 317d
Cleared Jul 11, 2000
THE KALIX IMPLANT
K001231
New Deal, S.A.
Orthopedic · 85d
Cleared Apr 26, 2000
BIOLOK SCREW
K993630
Encore Orthopedics, Inc.
Orthopedic · 182d
Cleared Apr 03, 2000
ASNIS III CANNULATED SCREW SYSTEM
K000080
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Mar 10, 2000
NONLINEAR TAPER LAG SCREW
K994382
Theken Surgical
Orthopedic · 73d
Cleared Mar 06, 2000
THE LIGAMENT ANCHOR SOFT SCREW
K994152
Corin USA
Orthopedic · 89d
Cleared Feb 25, 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM
K994202
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared Feb 04, 2000
I.CO.S SCREW
K993762
New Deal, S.A.
Orthopedic · 88d
Cleared Feb 03, 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
K000089
Synthes (Usa)
Orthopedic · 22d
Cleared Jan 12, 2000
BIORCI SCREW
K992396
Smith & Nephew Endoscopy, Inc.
Orthopedic · 177d
Cleared Dec 20, 1999
EIS THREADED SCREW FRACTURE FIXATION
K991964
Groupe Lepine
Orthopedic · 193d
Cleared Dec 20, 1999
ABSOLUTE ABSORBABLE INTERFERENCE SCREW
K993975
Innovasive Devices, Inc.
Orthopedic · 26d
Cleared Nov 18, 1999
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
K992945
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Nov 16, 1999
BONE BULLET SUTURE ANCHOR
K991024
Linvatec Corp.
Orthopedic · 232d
Cleared Oct 08, 1999
MODIFICATION TO BONE MULCH SCREW SYSTEM
K993025
Biomet, Inc.
Orthopedic · 29d
Cleared Sep 23, 1999
EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS
K992367
Electro-Biology, Inc.
Orthopedic · 70d
Cleared Sep 22, 1999
MITEK ROTATOR CUFF QUICKANCHOR PLUS
K992611
Mitek Products
Orthopedic · 49d
Cleared Sep 21, 1999
MITEK MINI QUICKANCHOR PLUS
K992487
Mitek Products
Orthopedic · 57d
Cleared Sep 21, 1999
CANNULATED SMARTSCREW MODELS 224540C, 224570C
K992947
Bionx Implants, Ltd.
Orthopedic · 20d
Cleared Sep 17, 1999
BIOBUTTON
K990194
Linvatec Corp.
Orthopedic · 239d
Cleared Sep 17, 1999
MODUS SYSTEM SELF-DRILLING SCREWS
K992106
Medartis AG
Orthopedic · 87d
Cleared Sep 01, 1999
REUNITE SCREWS
K992301
Biomet Manufacturing, Inc.
Orthopedic · 55d
Cleared Jul 30, 1999
BIORC ANCHOR
K990770
Linvatec Corp.
Orthopedic · 143d
Cleared Jul 30, 1999
STAPLETAC BONE ANCHOR SYSTEM
K992277
Influence, Inc.
Orthopedic · 23d