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
Nov 09, 2004
FASTIN RC ANCHOR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
197d
Cleared
Nov 05, 2004
ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
Coapt Systems, Inc.
Orthopedic
29d
Cleared
Nov 04, 2004
ARTHREX TRIMIT FAMILY
Arthrex, Inc.
Orthopedic
182d
Cleared
Nov 04, 2004
ARTHREX TENODESIS SCREW FAMILY
Arthrex, Inc.
Orthopedic
168d
Cleared
Nov 04, 2004
BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE
Linvatec Corp.
Orthopedic
29d
Cleared
Oct 20, 2004
SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
Scandius Biomedical, Inc.
Orthopedic
91d
Cleared
Oct 07, 2004
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
Synthes (Usa)
Orthopedic
37d
Cleared
Sep 28, 2004
ENDOTINE MIDFACE B 4.5 DEVICE
Coapt Systems, Inc.
General & Plastic Surgery
83d
Cleared
Sep 16, 2004
HYPROCURE SUBTALAR IMPLANT SYSTEM
Graham Medical Technologies, LLC
Orthopedic
50d
Cleared
Sep 16, 2004
BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
Triage Medical, Inc.
Orthopedic
28d
Cleared
Sep 16, 2004
SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
Linvatec Biomaterials, Ltd.
Orthopedic
23d
Cleared
Sep 16, 2004
ORTHO-PRO CANNULATED BONE SCREWS
Ortho-Pro, LLC
Orthopedic
22d
Cleared
Sep 08, 2004
SCANDIUS ACL RECONSTRUCTION SYSTEM
Scandius Biomedical, Inc.
Orthopedic
71d
Cleared
Sep 08, 2004
BIOPRO SUBTALAR IMPLANT
Biopro, Inc.
Orthopedic
51d
Cleared
Sep 01, 2004
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
Synthes (Usa)
Orthopedic
85d
Cleared
Aug 27, 2004
ENDOTINE FOREHEAD TRIPLE DEVICE
Coapt Systems, Inc.
Orthopedic
25d
Cleared
Aug 25, 2004
SNAP-OFF SCREWS
Fournitures Hospitalieres Industrie
Orthopedic
85d
Cleared
Aug 19, 2004
SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
Smith & Nephew, Inc.
Orthopedic
170d
Cleared
Aug 16, 2004
INION TRINION BIODEGRADABLE MENISCUS SCREW
Inion , Ltd.
Orthopedic
441d
Cleared
Aug 05, 2004
VILEX BONE PLATE SYSTEM
Vilex, Inc.
Orthopedic
84d
Cleared
Aug 05, 2004
TALUS OF VILEX (TOV)
Vilex, Inc.
Orthopedic
84d
Cleared
Jul 28, 2004
RESORBABLE INTERFERENCE SCREW
Arthrotek, Inc.
Orthopedic
77d
Cleared
Jun 30, 2004
LACTOSCREW SCREW ANCHOR
Biomet Orthopedics, Inc.
Orthopedic
254d
Cleared
Jun 24, 2004
BIO-EUROLIG INTERFERENCE SCREW
Fournitures Hospitalieres Industrie
Orthopedic
367d