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).
1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
Cleared
Jun 30, 2004
LACTOSCREW SCREW ANCHOR
Biomet Orthopedics, Inc.
Orthopedic
254d
Cleared
Jun 24, 2004
BIO-EUROLIG INTERFERENCE SCREW
Fournitures Hospitalieres Industrie
Orthopedic
367d
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
May 07, 2004
OSTEO ACL SCREW MODEL
Linvatec Biomaterials, Inc.
Orthopedic
233d
Cleared
Apr 16, 2004
CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED
Linvatec Biomaterials, Ltd.
Orthopedic
252d
Cleared
Apr 14, 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
Smith & Nephew, Inc.
Orthopedic
63d
Cleared
Mar 31, 2004
BIOCRYL RAPIDE INTERFERENCE SCREW
Mitek Worldwide
Orthopedic
211d
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
Feb 23, 2004
TITANIUM CANNULATED INTERFERENCE SCREW
Advanced Biomaterials
Orthopedic
84d
Cleared
Jan 15, 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
Acumed, LLC
Orthopedic
56d
Cleared
Jan 13, 2004
THE ANSWER SCREW SUPPLEMENTATION SYSTEM
Simplicity Orthopedic Solutions, LLC
Orthopedic
112d
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