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
481–504 of 1064
Cleared May 17, 2007
MODIFICATION TO BILOK ST SCREW
K071115
Biocomposites, Ltd.
Orthopedic · 27d
Cleared May 11, 2007
ALLOFIX PUSH-IN ANCHOR
K070347
Musculoskeletal Transplant Foundation
Orthopedic · 94d
Cleared May 11, 2007
ASNIS MICRO CANNULATED SCREW
K071092
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared May 09, 2007
STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937
K063584
Regeneration Technologies, Inc.
Orthopedic · 159d
Cleared May 08, 2007
METASURG SUBTALAR IMPLANT
K070441
Metasurg
Orthopedic · 82d
Cleared May 04, 2007
LAGWIRE SYSTEM
K070393
Fxdevices
Orthopedic · 84d
Cleared May 01, 2007
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
K070906
Zimmer, Inc.
Orthopedic · 29d
Cleared Mar 29, 2007
MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
K070507
Science For Biomaterials
Orthopedic · 36d
Cleared Mar 29, 2007
CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
K070525
Wrightmedicaltechnologyinc
Orthopedic · 34d
Cleared Mar 21, 2007
MEMOMETAL FIXOS SCREWS
K070039
Memometal Technologies
Orthopedic · 77d
Cleared Mar 15, 2007
UNITY ALPHA SYSTEM
K062820
Bonutti Research, Inc.
Orthopedic · 176d
Cleared Mar 02, 2007
OSTEOMED HEADLESS CANNULATED SCREW SYSTEM
K063298
Osteomed LP
Orthopedic · 121d
Cleared Mar 02, 2007
MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5
K063588
Conmed Linvatec Biomaterials
Orthopedic · 92d
Cleared Jan 31, 2007
GSO BONE FIXATION FASTENERS
K063589
Gold Standard Orthopaedics, LLC
Orthopedic · 61d
Cleared Dec 27, 2006
ARC SURGICAL BONE REDUCTION SCREW
K063244
Arc Surgical, LLC
Orthopedic · 62d
Cleared Dec 15, 2006
VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810)
K063478
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 28d
Cleared Dec 14, 2006
APERFIX TIBIAL IMPLANT WITH INSERTER
K063070
Cayenne Medical, Inc.
Orthopedic · 69d
Cleared Dec 13, 2006
ARTHREX PUSHLOCK
K063479
Arthrex, Inc.
Orthopedic · 26d
Cleared Nov 22, 2006
ACTIVASCREW
K062980
Bioretec, Ltd.
Orthopedic · 54d
Cleared Nov 17, 2006
APERFIX FEMORAL IMPLANT WITH INSERTER
K062487
Cayenne Medical, Inc.
Orthopedic · 84d
Cleared Oct 31, 2006
OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM
K062863
Osteomed LP
Orthopedic · 36d
Cleared Oct 25, 2006
DARCO FORCE TITANIUM COMPRESSION SCREW
K062103
Darco International, Inc.
Orthopedic · 93d
Cleared Oct 19, 2006
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY
K061863
Arthrex, Inc.
Orthopedic · 111d
Cleared Oct 19, 2006
FRS SCREW
K062352
DePuy Orthopaedics, Inc.
Orthopedic · 69d