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
553–576 of 1064
Cleared Jun 17, 2005
ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM
K043176
Arc Surgical, LLC
Orthopedic · 213d
Cleared Jun 09, 2005
STERLING INTERFERENCE SCREW ST
K050767
Regeneration Technologies, Inc.
Orthopedic · 76d
Cleared May 27, 2005
MERETE DUOTHREADTM BONE SCREW
K050924
Merete Medical GmbH
Orthopedic · 44d
Cleared May 18, 2005
PRECIMED CANNULATED SCREW SYSTEM
K050754
Precimed, Inc.
Orthopedic · 56d
Cleared May 12, 2005
ARTHREX TAK FAMILY
K050749
Arthrex, Inc.
Orthopedic · 50d
Cleared Apr 27, 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683
Synthes (Usa)
Orthopedic · 41d
Cleared Apr 21, 2005
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
K050636
Synthes (Usa)
Orthopedic · 41d
Cleared Apr 15, 2005
ARTHERX CORKSCREW FT II SUTURE ANCHOR
K050358
Arthrex, Inc.
Orthopedic · 60d
Cleared Apr 11, 2005
CHARLOTTE SNAP-OFF SCREW
K050819
Wrightmedicaltechnologyinc
Orthopedic · 11d
Cleared Mar 25, 2005
BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET
K050497
Linvatec Corp.
Orthopedic · 25d
Cleared Mar 21, 2005
MODIFICATION TO: ARTHREX V-TAK
K050634
Arthrex, Inc.
Orthopedic · 12d
Cleared Mar 17, 2005
STABILIZATION SCREW
K050346
New Deal, S.A.
Orthopedic · 34d
Cleared Feb 24, 2005
EPIPHYSIS SCREW
K043410
I.T.S. Implantat-Technologie-Systeme GmbH
Orthopedic · 76d
Cleared Feb 18, 2005
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K043142
Inion , Ltd.
Orthopedic · 95d
Cleared Feb 11, 2005
ASIAN INTRAMEDULLARY HIP SCREW NAILS
K050226
Smith & Nephew, Inc.
Orthopedic · 10d
Cleared Feb 03, 2005
SYNTHES 3.5MM CORTEX SCREWS
K043185
Synthes (Usa)
Orthopedic · 78d
Cleared Jan 26, 2005
CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
K043583
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Jan 21, 2005
MULTI-USE COMPRESSION SCREW
K043102
Wrightmedicaltechnologyinc
Orthopedic · 73d
Cleared Jan 19, 2005
CHARLOTTE HIGH-DEMAND COMPRESSION SCREW
K043281
Wrightmedicaltechnologyinc
Orthopedic · 54d
Cleared Dec 20, 2004
OSS/(SCARF)- AND OSW-SCREW
K042079
O.M.T. Oberflachen-Und Materialtechnologie GmbH
Orthopedic · 140d
Cleared Dec 14, 2004
BIO-CORE INTERFERENCE SCREW
K042552
Biomet, Inc.
Orthopedic · 85d
Cleared Dec 14, 2004
OPUS MINIMAGNUM ANCHOR WITH INSERTER
K042584
Opus Medical, Inc.
Orthopedic · 83d
Cleared Dec 14, 2004
ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
K043337
Arthrex, Inc.
Orthopedic · 11d
Cleared Nov 09, 2004
SPIRALOK ANCHOR
K041069
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 197d