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
577–600 of 1064
Cleared Nov 09, 2004
FASTIN RC ANCHOR
K041075
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 197d
Cleared Nov 05, 2004
ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
K042796
Coapt Systems, Inc.
Orthopedic · 29d
Cleared Nov 04, 2004
ARTHREX TRIMIT FAMILY
K041189
Arthrex, Inc.
Orthopedic · 182d
Cleared Nov 04, 2004
ARTHREX TENODESIS SCREW FAMILY
K041356
Arthrex, Inc.
Orthopedic · 168d
Cleared Nov 04, 2004
BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE
K042778
Linvatec Corp.
Orthopedic · 29d
Cleared Oct 20, 2004
SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
K041961
Scandius Biomedical, Inc.
Orthopedic · 91d
Cleared Oct 07, 2004
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
K042356
Synthes (Usa)
Orthopedic · 37d
Cleared Sep 28, 2004
ENDOTINE MIDFACE B 4.5 DEVICE
K041835
Coapt Systems, Inc.
General & Plastic Surgery · 83d
Cleared Sep 16, 2004
HYPROCURE SUBTALAR IMPLANT SYSTEM
K042030
Graham Medical Technologies, LLC
Orthopedic · 50d
Cleared Sep 16, 2004
BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
K042244
Triage Medical, Inc.
Orthopedic · 28d
Cleared Sep 16, 2004
SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
K042295
Linvatec Biomaterials, Ltd.
Orthopedic · 23d
Cleared Sep 16, 2004
ORTHO-PRO CANNULATED BONE SCREWS
K042310
Ortho-Pro, LLC
Orthopedic · 22d
Cleared Sep 08, 2004
SCANDIUS ACL RECONSTRUCTION SYSTEM
K041749
Scandius Biomedical, Inc.
Orthopedic · 71d
Cleared Sep 08, 2004
BIOPRO SUBTALAR IMPLANT
K041936
Biopro, Inc.
Orthopedic · 51d
Cleared Sep 01, 2004
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
K041533
Synthes (Usa)
Orthopedic · 85d
Cleared Aug 27, 2004
ENDOTINE FOREHEAD TRIPLE DEVICE
K042078
Coapt Systems, Inc.
Orthopedic · 25d
Cleared Aug 25, 2004
SNAP-OFF SCREWS
K041456
Fournitures Hospitalieres Industrie
Orthopedic · 85d
Cleared Aug 19, 2004
SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
K040542
Smith & Nephew, Inc.
Orthopedic · 170d
Cleared Aug 16, 2004
INION TRINION BIODEGRADABLE MENISCUS SCREW
K031714
Inion , Ltd.
Orthopedic · 441d
Cleared Aug 05, 2004
VILEX BONE PLATE SYSTEM
K041287
Vilex, Inc.
Orthopedic · 84d
Cleared Aug 05, 2004
TALUS OF VILEX (TOV)
K041289
Vilex, Inc.
Orthopedic · 84d
Cleared Jul 28, 2004
RESORBABLE INTERFERENCE SCREW
K041274
Arthrotek, Inc.
Orthopedic · 77d
Cleared Jun 30, 2004
LACTOSCREW SCREW ANCHOR
K033355
Biomet Orthopedics, Inc.
Orthopedic · 254d
Cleared Jun 24, 2004
BIO-EUROLIG INTERFERENCE SCREW
K031939
Fournitures Hospitalieres Industrie
Orthopedic · 367d