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., Wrightmedicaltechnologyinc and Synthes (Usa).

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
601–624 of 1064
Cleared Jun 15, 2004
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
K040701
Synthes (Usa)
Orthopedic · 90d
Cleared May 28, 2004
LITTLE GRAFTER SCREW
K040265
Biocomposites, Ltd.
Orthopedic · 113d
Cleared May 25, 2004
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
K040656
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared May 21, 2004
MICROMAX SUTURE ANCHOR
K040475
Biomet, Inc.
Orthopedic · 87d
Cleared May 10, 2004
ENDOTINE TRANSBLEPH DEVICE
K040740
Coapt Systems, Inc.
Orthopedic · 49d
Cleared Apr 14, 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
K040331
Smith & Nephew, Inc.
Orthopedic · 63d
Cleared Mar 31, 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594
United States Surgical, A Division of Tyco Healthc
Orthopedic · 23d
Cleared Mar 01, 2004
BILOK ST SCREW
K033792
Biocomposites, Ltd.
Orthopedic · 87d
Cleared Mar 01, 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975
Synthes (Usa)
Orthopedic · 69d
Cleared Mar 01, 2004
KOMPRESSOR SCREW SYSTEM
K040356
Kinetikos Medical, Inc.
Orthopedic · 17d
Cleared Jan 15, 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
K033639
Acumed, LLC
Orthopedic · 56d
Cleared Dec 31, 2003
BIOANCHOR WITH DISPOSABLE DRIVER
K033804
Linvatec Corp.
Orthopedic · 23d
Cleared Dec 18, 2003
COAPT ENDOTINE CHIN 3.5 DEVICE
K033524
Coapt Systems, Inc.
General & Plastic Surgery · 41d
Cleared Dec 15, 2003
SUBTALAR ARTHRORISIS IMPLANT
K032902
Nexa Orthopedics, Inc.
Orthopedic · 89d
Cleared Dec 15, 2003
LORENZ STERNAL CLOSURE SYSTEM
K033740
Walter Lorenz Surgical, Inc.
Orthopedic · 17d
Cleared Nov 13, 2003
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K033252
Stryker Endoscopy
Orthopedic · 36d
Cleared Nov 05, 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233
Biomet, Inc.
Orthopedic · 30d
Cleared Oct 08, 2003
ENDOTINE FOREHEAD DEVICE
K032770
Coapt Systems, Inc.
Orthopedic · 30d
Cleared Oct 07, 2003
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B
K032098
Arthrex, Inc.
Orthopedic · 91d
Cleared Oct 01, 2003
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE
K032072
Arthrotek, Inc.
Orthopedic · 90d
Cleared Sep 22, 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
K031945
Arthrex, Inc.
Orthopedic · 90d
Cleared Sep 04, 2003
ALANTECH GRAFT FIXATION SCREW
K031937
Arthrocare Corp.
Orthopedic · 73d
Cleared Aug 22, 2003
OSTEOMED SUBTALAR IMPLANT SYSTEM
K031155
Osteomed LP
Orthopedic · 133d
Cleared Aug 11, 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228
Walter Lorenz Surgical, Inc.
Orthopedic · 21d