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
Jul 14, 1999
SPIN SNAP-OFF SCREW
New Deal, S.A.
Orthopedic
77d
Cleared
Jul 01, 1999
BIO-INTERFERENCE SCREW
Innovasive Devices, Inc.
Orthopedic
139d
Cleared
Jun 01, 1999
BONE SCREWS
Bregma International Trading Company , Ltd.
Orthopedic
116d
Cleared
May 14, 1999
BONE MULCH SCREW SYSTEM
Biomet, Inc.
Orthopedic
29d
Cleared
Apr 29, 1999
BOLD SCREW
New Deal, S.A.
Orthopedic
63d
Cleared
Apr 29, 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
Aap Implantate AG
Orthopedic
51d
Cleared
Apr 29, 1999
STAYFUSE
Pioneer Surgical Technology
Orthopedic
50d
Cleared
Apr 26, 1999
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW
Vilex, Inc.
Orthopedic
20d
Cleared
Apr 26, 1999
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24
Vilex, Inc.
Orthopedic
19d
Cleared
Mar 17, 1999
ULTIMAX CORTICAL BONE SCREWS
Biodynamic Technologies, Inc.
Orthopedic
27d
Cleared
Mar 15, 1999
DRG MEDIUM SCREW SYSTEM
Dolphin Medical Technologies, Inc.
Orthopedic
70d
Cleared
Feb 03, 1999
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
Biomet, Inc.
Orthopedic
71d
Cleared
Jan 28, 1999
SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
Sulzer Orthopedics, Inc.
Orthopedic
107d
Cleared
Jan 28, 1999
BIOABSORBABLE INTERFERENCE SCREWS
Smith & Nephew, Inc.
Orthopedic
56d
Cleared
Jan 20, 1999
ODI ULTIMATE COMPRESSION HIP SCREW
Orthopedic Designs, Inc.
Orthopedic
48d
Cleared
Dec 22, 1998
PHUSIS ABSORBABLE INTERFERENCE SCREW
Tornier
Orthopedic
656d
Cleared
Dec 16, 1998
SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420
Syntec Scientific Corp.
Orthopedic
72d
Cleared
Dec 07, 1998
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
Osteonics Corp.
Orthopedic
61d
Cleared
Dec 03, 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
Osteonics Corp.
Orthopedic
84d
Cleared
Nov 23, 1998
OSTEO 5.0MM CANNULATED SCREW SYSTEM
Stryker Osteonics
Orthopedic
87d
Cleared
Oct 28, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
DePuy Orthopaedics, Inc.
Orthopedic
90d
Cleared
Oct 16, 1998
ARTHROTEK INTERFERENCE SCREW
Biomet, Inc.
Orthopedic
88d
Cleared
Sep 08, 1998
ENDO ABSORBABLE INTERFERENCE SCREW
Endo Surgical Concepts, Inc.
Orthopedic
215d
Cleared
Jul 29, 1998
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM
Synthes (Usa)
Orthopedic
35d