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
May 17, 2007
MODIFICATION TO BILOK ST SCREW
Biocomposites, Ltd.
Orthopedic
27d
Cleared
May 11, 2007
ALLOFIX PUSH-IN ANCHOR
Musculoskeletal Transplant Foundation
Orthopedic
94d
Cleared
May 11, 2007
ASNIS MICRO CANNULATED SCREW
Howmedica Osteonics Corp.
Orthopedic
23d
Cleared
May 09, 2007
STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937
Regeneration Technologies, Inc.
Orthopedic
159d
Cleared
May 08, 2007
METASURG SUBTALAR IMPLANT
Metasurg
Orthopedic
82d
Cleared
May 04, 2007
LAGWIRE SYSTEM
Fxdevices
Orthopedic
84d
Cleared
May 01, 2007
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
Zimmer, Inc.
Orthopedic
29d
Cleared
Mar 29, 2007
MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
Science For Biomaterials
Orthopedic
36d
Cleared
Mar 29, 2007
CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
Wrightmedicaltechnologyinc
Orthopedic
34d
Cleared
Mar 21, 2007
MEMOMETAL FIXOS SCREWS
Memometal Technologies
Orthopedic
77d
Cleared
Mar 15, 2007
UNITY ALPHA SYSTEM
Bonutti Research, Inc.
Orthopedic
176d
Cleared
Mar 02, 2007
OSTEOMED HEADLESS CANNULATED SCREW SYSTEM
Osteomed LP
Orthopedic
121d
Cleared
Mar 02, 2007
MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5
Conmed Linvatec Biomaterials
Orthopedic
92d
Cleared
Jan 31, 2007
GSO BONE FIXATION FASTENERS
Gold Standard Orthopaedics, LLC
Orthopedic
61d
Cleared
Dec 27, 2006
ARC SURGICAL BONE REDUCTION SCREW
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)
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
28d
Cleared
Dec 14, 2006
APERFIX TIBIAL IMPLANT WITH INSERTER
Cayenne Medical, Inc.
Orthopedic
69d
Cleared
Dec 13, 2006
ARTHREX PUSHLOCK
Arthrex, Inc.
Orthopedic
26d
Cleared
Nov 22, 2006
ACTIVASCREW
Bioretec, Ltd.
Orthopedic
54d
Cleared
Nov 17, 2006
APERFIX FEMORAL IMPLANT WITH INSERTER
Cayenne Medical, Inc.
Orthopedic
84d
Cleared
Oct 31, 2006
OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM
Osteomed LP
Orthopedic
36d
Cleared
Oct 25, 2006
DARCO FORCE TITANIUM COMPRESSION SCREW
Darco International, Inc.
Orthopedic
93d
Cleared
Oct 19, 2006
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY
Arthrex, Inc.
Orthopedic
111d
Cleared
Oct 19, 2006
FRS SCREW
DePuy Orthopaedics, Inc.
Orthopedic
69d