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).
1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
Cleared
May 15, 2014
SMITH & NEPHEW CANNULATED CAPTURED SCREW
Smith & Nephew, Inc.
Orthopedic
167d
Cleared
May 15, 2014
SALVATION BEAMS AND BOLTS SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
51d
Cleared
May 15, 2014
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
Wrightmedicaltechnologyinc
Orthopedic
31d
Cleared
May 14, 2014
SALVATION OSTEOPENIC SCREW
Wrightmedicaltechnologyinc
Orthopedic
85d
Cleared
Mar 07, 2014
CHARLOTTE (TM) SNAP-OFF SCREW
Wrightmedicaltechnologyinc
Orthopedic
92d
Cleared
Mar 07, 2014
PRO-TOE HAMMERTOE FIXATION SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
44d
Cleared
Nov 25, 2013
ARTHREX COMPRESSION FT SCREWS
Arthrex, Inc.
Orthopedic
131d
Cleared
Sep 19, 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
Zimmer, Inc.
Orthopedic
178d
Cleared
May 31, 2013
MEDLINE CANNULATED SCREW
Medline Industries, Inc.
Orthopedic
112d
Cleared
Nov 20, 2012
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
Smith & Nephew, Inc.
Orthopedic
88d
Cleared
Apr 24, 2012
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
Wrightmedicaltechnologyinc
Orthopedic
53d
Cleared
Dec 19, 2011
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
Zimmer, Inc.
Orthopedic
80d
Cleared
Oct 11, 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
Smith & Nephew, Inc.
Orthopedic
90d
Cleared
Oct 07, 2011
ORTHOLOC(TM) BONE SCREWS
Wrightmedicaltechnologyinc
Orthopedic
14d
Cleared
Oct 05, 2011
ZIMMER PERIARTICULAR SCREWS
Zimmer, Inc.
Orthopedic
134d
Cleared
Sep 02, 2011
MICROSUTURE ANCHORS
Arthrex, Inc.
Orthopedic
29d
Cleared
Jul 25, 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
Synthes (Usa)
Orthopedic
145d
Cleared
May 04, 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
260d
Cleared
Mar 18, 2011
LOW PROFILE SCREWS
Arthrex, Inc.
Orthopedic
88d
Cleared
Sep 10, 2010
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
Zimmer, Inc.
Orthopedic
86d
Cleared
Jul 23, 2010
PRO-TOE VO HAMMERTOW IMPLANT SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
88d
Cleared
Jun 24, 2010
DARCO HEADED CANNULATED SCREW
Wrightmedicaltechnologyinc
Orthopedic
132d
Cleared
May 04, 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
Smith & Nephew, Inc.
Orthopedic
89d
Cleared
Jan 11, 2010
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
Synthes (Usa)
Orthopedic
111d