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).

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
793–816 of 1070
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
Cleared Jul 14, 1999
SPIN SNAP-OFF SCREW
K991477
New Deal, S.A.
Orthopedic · 77d
Cleared Jul 01, 1999
BIO-INTERFERENCE SCREW
K990454
Innovasive Devices, Inc.
Orthopedic · 139d
Cleared Jun 01, 1999
BONE SCREWS
K990351
Bregma International Trading Company , Ltd.
Orthopedic · 116d
Cleared May 14, 1999
BONE MULCH SCREW SYSTEM
K991298
Biomet, Inc.
Orthopedic · 29d
Cleared Apr 29, 1999
BOLD SCREW
K990622
New Deal, S.A.
Orthopedic · 63d
Cleared Apr 29, 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
K990776
Aap Implantate AG
Orthopedic · 51d
Cleared Apr 29, 1999
STAYFUSE
K990804
Pioneer Surgical Technology
Orthopedic · 50d
Cleared Apr 26, 1999
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW
K991151
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
K991197
Vilex, Inc.
Orthopedic · 19d