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).
1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
Cleared
Apr 03, 1997
BIOMET BONE SCREW
Biomet, Inc.
Orthopedic
112d
Cleared
Feb 27, 1997
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
Smith & Nephew, Inc.
Orthopedic
70d
Cleared
Jan 22, 1997
LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
Howmedica Leibinger, Inc.
Orthopedic
127d
Cleared
Jan 22, 1997
NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW
Northwest Precision Technologies
Orthopedic
113d
Cleared
Nov 18, 1996
HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)
Depuy, Inc.
Orthopedic
336d
Cleared
Nov 14, 1996
BIOSCREW ABSORBABLE INTERFERENCE SCREW
Linvatec Corp.
Orthopedic
273d
Cleared
Nov 14, 1996
DEPUY MOTECH PEAK FIXATION SYSTEM
Depuy, Inc.
Orthopedic
80d
Cleared
Nov 13, 1996
EZ-FIX CANNULATED SCREW SYSTEM
Biodynamic Technologies, Inc.
Orthopedic
124d
Cleared
Nov 08, 1996
SYNTHES STERILE 4.5 MM CANNULATED SCREWS
Synthes (Usa)
Orthopedic
86d
Cleared
Nov 08, 1996
SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS
Synthes (Usa)
Orthopedic
85d
Cleared
Nov 04, 1996
EZ-FIX SMALL CANNULATED SCREW SYSTEM
Biodynamic Technologies, Inc.
Orthopedic
95d
Cleared
Oct 10, 1996
EXTREMITY BONE SCREW
Acu Med, Inc.
Orthopedic
59d
Cleared
Oct 10, 1996
ALTA FULLY THREADED CROSS-LOCKING SCREWS
Howmedica Corp.
Orthopedic
42d
Cleared
Oct 03, 1996
TWIST-OFF SCREW
Landos, Inc.
Orthopedic
114d
Cleared
Oct 01, 1996
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
Synthes (Usa)
Orthopedic
74d
Cleared
Sep 20, 1996
SCARF THREAD-HEAD SCREW
Landos, Inc.
Orthopedic
101d
Cleared
Aug 23, 1996
COMPRESSION SCREW
Orthopaedic Biosystems, Ltd.
Orthopedic
37d
Cleared
Aug 19, 1996
INTERFERENCE SCREW
Linvatec Corp.
Orthopedic
161d
Cleared
Aug 15, 1996
BIOSCREW ABSORBABLE INTERFERENCE SCREW
Linvatec Corp.
Orthopedic
160d
Cleared
Aug 07, 1996
SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
Synthes (Usa)
Orthopedic
117d
Cleared
Aug 06, 1996
MEDICINELODGE, INC. SET SCREW
Medicinelodge, Inc.
Orthopedic
82d
Cleared
Aug 05, 1996
SYNTHES 7.0/7.3 MM CANNULATED SCREWS
Synthes (Usa)
Orthopedic
74d
Cleared
Jul 23, 1996
SUBTALAR MBA SYSTEM
Kinetikos Medical, Inc.
Orthopedic
154d
Cleared
Jul 16, 1996
ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER
Smith & Nephew Endoscopy, Inc.
Orthopedic
77d