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).

1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
217–240 of 1059
Cleared May 15, 2014
SMITH & NEPHEW CANNULATED CAPTURED SCREW
K133662
Smith & Nephew, Inc.
Orthopedic · 167d
Cleared May 15, 2014
SALVATION BEAMS AND BOLTS SYSTEM
K140741
Wrightmedicaltechnologyinc
Orthopedic · 51d
Cleared May 15, 2014
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
K140952
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared May 14, 2014
SALVATION OSTEOPENIC SCREW
K140408
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Mar 07, 2014
CHARLOTTE (TM) SNAP-OFF SCREW
K133713
Wrightmedicaltechnologyinc
Orthopedic · 92d
Cleared Mar 07, 2014
PRO-TOE HAMMERTOE FIXATION SYSTEM
K140148
Wrightmedicaltechnologyinc
Orthopedic · 44d
Cleared Nov 25, 2013
ARTHREX COMPRESSION FT SCREWS
K132217
Arthrex, Inc.
Orthopedic · 131d
Cleared Sep 19, 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810
Zimmer, Inc.
Orthopedic · 178d
Cleared May 31, 2013
MEDLINE CANNULATED SCREW
K130319
Medline Industries, Inc.
Orthopedic · 112d
Cleared Nov 20, 2012
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Apr 24, 2012
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
K120645
Wrightmedicaltechnologyinc
Orthopedic · 53d
Cleared Dec 19, 2011
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885
Zimmer, Inc.
Orthopedic · 80d
Cleared Oct 11, 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Oct 07, 2011
ORTHOLOC(TM) BONE SCREWS
K112772
Wrightmedicaltechnologyinc
Orthopedic · 14d
Cleared Oct 05, 2011
ZIMMER PERIARTICULAR SCREWS
K111447
Zimmer, Inc.
Orthopedic · 134d
Cleared Sep 02, 2011
MICROSUTURE ANCHORS
K112237
Arthrex, Inc.
Orthopedic · 29d
Cleared Jul 25, 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592
Synthes (Usa)
Orthopedic · 145d
Cleared May 04, 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
K102324
Wrightmedicaltechnologyinc
Orthopedic · 260d
Cleared Mar 18, 2011
LOW PROFILE SCREWS
K103705
Arthrex, Inc.
Orthopedic · 88d
Cleared Sep 10, 2010
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
K101696
Zimmer, Inc.
Orthopedic · 86d
Cleared Jul 23, 2010
PRO-TOE VO HAMMERTOW IMPLANT SYSTEM
K101165
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Jun 24, 2010
DARCO HEADED CANNULATED SCREW
K100359
Wrightmedicaltechnologyinc
Orthopedic · 132d
Cleared May 04, 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
K100325
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Jan 11, 2010
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
K092909
Synthes (Usa)
Orthopedic · 111d