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., Synthes (Usa) and Wrightmedicaltechnologyinc.
1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
Cleared
Oct 04, 2006
MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM
Inion , Ltd.
Orthopedic
29d
Cleared
Sep 27, 2006
ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES
Arthrex, Inc.
Orthopedic
19d
Cleared
Sep 25, 2006
DOUBLEPLAY SUTURE ANCHOR
Biocomposites, Ltd.
Orthopedic
77d
Cleared
Sep 19, 2006
ARC SURGICAL BIOTRAK SCREW
Arc Surgical, LLC
Orthopedic
89d
Cleared
Sep 08, 2006
TIMESH SELF DRILLING SCREW
Medtronic Neurosurgery
Orthopedic
28d
Cleared
Jul 27, 2006
SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
Synthes (Usa)
Orthopedic
45d
Cleared
Jul 26, 2006
IFS CANNULATED BONE SCREW
Internal Fixation Systems, Inc.
Orthopedic
47d
Cleared
Jul 25, 2006
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT
Arthrex, Inc.
Orthopedic
41d
Cleared
Jul 18, 2006
KALIX II IMPLANT
New Deal, S.A.
Orthopedic
26d
Cleared
Jul 05, 2006
LIGAFIX INTERFERENCE SCREW
Sciences For Bio Materials
Orthopedic
61d
Cleared
Jun 19, 2006
ACUTE BONE SCREW
Acute Innovations, LLC
Orthopedic
49d
Cleared
Jun 15, 2006
MILAGRO INTERFERENCE SCREW
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
80d
Cleared
Jun 12, 2006
ULTRATINE TRANSBLEPH
Coapt Systems, Inc.
Orthopedic
132d
Cleared
Jun 12, 2006
ULTRATINE FOREHEAD
Coapt Systems, Inc.
Orthopedic
132d
Cleared
Jun 09, 2006
TRIDENT ANCHOR
Johnson & Johnson Company
Orthopedic
66d
Cleared
Jun 06, 2006
FASTIN RC ANCHOR
Depuy Mitek
Orthopedic
85d
Cleared
Jun 06, 2006
MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR
Arthrotek, Inc.
Orthopedic
83d
Cleared
May 19, 2006
ARTHREX BIO-COMPRESSION SCREW
Arthrex, Inc.
Orthopedic
85d
Cleared
May 04, 2006
SPIRALOK ANCHOR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
92d
Cleared
Apr 26, 2006
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
Zimmer, Inc.
Orthopedic
41d
Cleared
Apr 18, 2006
SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
Smith & Nephew, Inc.
Orthopedic
29d
Cleared
Apr 06, 2006
HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
Conmed Linvatec
Orthopedic
20d
Cleared
Apr 03, 2006
ARTHREX ARTHOERESIS IMPLANT
Arthrex, Inc.
Orthopedic
104d
Cleared
Mar 13, 2006
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
Inion , Ltd.
Orthopedic
26d