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.
1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
Cleared
Aug 19, 2004
SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
Smith & Nephew, Inc.
Orthopedic
170d
Cleared
Jun 15, 2004
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
Synthes (Usa)
Orthopedic
90d
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
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
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
Synthes (Usa)
Orthopedic
69d
Cleared
Nov 05, 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
Biomet, 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
Sep 22, 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
Arthrex, Inc.
Orthopedic
90d
Cleared
Aug 08, 2003
BIORCI SCREW
Smith & Nephew, Inc.
Orthopedic
18d
Cleared
Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
Smith & Nephew, Inc.
Orthopedic
29d
Cleared
Mar 20, 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
KARL STORZ Endoscopy-America, Inc.
Orthopedic
44d
Cleared
Dec 20, 2002
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
Howmedica Osteonics Corp.
Orthopedic
11d
Cleared
Dec 02, 2002
MODULAR HEAD BONE SCREW
Biomet, Inc.
Orthopedic
88d
Cleared
Oct 09, 2002
BOSWORTH CORACO-CLAVICULAR SCREW
Howmedica Osteonics Corp.
Orthopedic
7d
Cleared
Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
Smith & Nephew, Inc.
Orthopedic
23d
Cleared
Oct 03, 2002
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
Arthrex, Inc.
Orthopedic
84d
Cleared
Sep 06, 2002
SYNTHES 6.5 MM CANNULATED SCREW
Synthes (Usa)
Orthopedic
86d
Cleared
Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
Synthes (Usa)
Orthopedic
88d
Cleared
Jul 01, 2002
SMALL HAMMER TOE PIN
Biomet, Inc.
Orthopedic
27d
Cleared
Jun 26, 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
Biomet, Inc.
Orthopedic
22d
Cleared
Apr 02, 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
Arthrex, Inc.
Orthopedic
85d
Cleared
Mar 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
Smith & Nephew, Inc.
Orthopedic
68d