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