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