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.

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
721–744 of 1070
Cleared Jul 01, 2002
BIOFASTIN RC THREADED SUTURE ANCHOR
K021883
Mitek Worldwide
Orthopedic · 24d
Cleared Jun 26, 2002
DUET SUTURE ANCHOR
K020056
Bionx Implants, Ltd.
Orthopedic · 169d
Cleared Jun 26, 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832
Biomet, Inc.
Orthopedic · 22d
Cleared Jun 25, 2002
TITANIUM CANNULATED INTERFERENCE SCREW
K021030
Future Medical Systems, Inc.
Orthopedic · 88d
Cleared Jun 11, 2002
BIOSCREW XTRALOK
K013131
Linvatec Corp.
Orthopedic · 265d
Cleared Jun 06, 2002
HBS HEADLESS BONE SCREW
K020791
Millennium Medical Technologies, Inc.
Orthopedic · 87d
Cleared May 06, 2002
PRE-LOADED BIOSTINGER HORNET
K020377
Linvatec Corp.
Orthopedic · 90d
Cleared Apr 02, 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043
Arthrex, Inc.
Orthopedic · 85d
Cleared Mar 27, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
K014304
Triage Medical, Inc.
Orthopedic · 86d
Cleared Mar 26, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050
K014243
Triage Medical, Inc.
Orthopedic · 90d
Cleared Mar 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Mar 18, 2002
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09
K014154
Vilex, Inc.
Orthopedic · 90d
Cleared Mar 15, 2002
COAPT SYSTMES ENDOTINE DEVICE
K014153
Coapt Systems, Inc.
Orthopedic · 87d
Cleared Mar 14, 2002
MITEK BIOCRYL INTERFERENCE SCREWS
K013572
Mitek Products
Orthopedic · 136d
Cleared Mar 13, 2002
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K020446
American Medical Systems, Inc.
General & Plastic Surgery · 30d
Cleared Feb 28, 2002
LORENZ SELF DRILLING SCREWS
K013954
Walter Lorenz Surgical, Inc.
Orthopedic · 90d
Cleared Feb 26, 2002
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K013107
Karl Storz Endoscopy
Orthopedic · 162d
Cleared Feb 26, 2002
SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE
K020352
Unitedstates Surgical
Orthopedic · 22d
Cleared Feb 22, 2002
INION CPS BSSO SCREW
K020266
Inion , Ltd.
Dental · 28d
Cleared Feb 13, 2002
AOS CANNULATED BONE SCREW SYSTEM
K014185
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 55d
Cleared Jan 18, 2002
PLLA CANNULATED INTERFERENCE SCREW
K013685
Future Medical Systems, Inc.
Orthopedic · 72d
Cleared Dec 17, 2001
SELF-COUNTERSINKING BONE SCREW
K013534
Biomet Orthopedics, Inc.
Orthopedic · 55d
Cleared Dec 17, 2001
DRG ORTHOHEX SS BONE SCREW
K013786
Doctor'S Research Group, Inc.
Orthopedic · 33d
Cleared Dec 17, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
K013903
Triad Medical, Inc.
Orthopedic · 21d