HWC · Class II · 21 CFR 888.3040

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
505–528 of 1064
Cleared Oct 04, 2006
MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM
K062617
Inion , Ltd.
Orthopedic · 29d
Cleared Sep 27, 2006
ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES
K062679
Arthrex, Inc.
Orthopedic · 19d
Cleared Sep 25, 2006
DOUBLEPLAY SUTURE ANCHOR
K061949
Biocomposites, Ltd.
Orthopedic · 77d
Cleared Sep 19, 2006
ARC SURGICAL BIOTRAK SCREW
K061763
Arc Surgical, LLC
Orthopedic · 89d
Cleared Sep 08, 2006
TIMESH SELF DRILLING SCREW
K062348
Medtronic Neurosurgery
Orthopedic · 28d
Cleared Jul 27, 2006
SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
K061621
Synthes (Usa)
Orthopedic · 45d
Cleared Jul 26, 2006
IFS CANNULATED BONE SCREW
K061620
Internal Fixation Systems, Inc.
Orthopedic · 47d
Cleared Jul 25, 2006
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT
K061665
Arthrex, Inc.
Orthopedic · 41d
Cleared Jul 18, 2006
KALIX II IMPLANT
K061765
New Deal, S.A.
Orthopedic · 26d
Cleared Jul 05, 2006
LIGAFIX INTERFERENCE SCREW
K061262
Sciences For Bio Materials
Orthopedic · 61d
Cleared Jun 19, 2006
ACUTE BONE SCREW
K061206
Acute Innovations, LLC
Orthopedic · 49d
Cleared Jun 15, 2006
MILAGRO INTERFERENCE SCREW
K060830
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 80d
Cleared Jun 12, 2006
ULTRATINE TRANSBLEPH
K060248
Coapt Systems, Inc.
Orthopedic · 132d
Cleared Jun 12, 2006
ULTRATINE FOREHEAD
K060249
Coapt Systems, Inc.
Orthopedic · 132d
Cleared Jun 09, 2006
TRIDENT ANCHOR
K060914
Johnson & Johnson Company
Orthopedic · 66d
Cleared Jun 06, 2006
FASTIN RC ANCHOR
K060664
Depuy Mitek
Orthopedic · 85d
Cleared Jun 06, 2006
MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR
K060693
Arthrotek, Inc.
Orthopedic · 83d
Cleared May 19, 2006
ARTHREX BIO-COMPRESSION SCREW
K060478
Arthrex, Inc.
Orthopedic · 85d
Cleared May 04, 2006
SPIRALOK ANCHOR
K060271
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 92d
Cleared Apr 26, 2006
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
K060710
Zimmer, Inc.
Orthopedic · 41d
Cleared Apr 18, 2006
SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
K060736
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Apr 06, 2006
HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
K060714
Conmed Linvatec
Orthopedic · 20d
Cleared Apr 03, 2006
ARTHREX ARTHOERESIS IMPLANT
K053543
Arthrex, Inc.
Orthopedic · 104d
Cleared Mar 13, 2006
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K060393
Inion , Ltd.
Orthopedic · 26d