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
Oct 22, 2003
STS SCREW
Ortho-Pro, LLC
Orthopedic
54d
Cleared
Oct 15, 2003
BIO-INTRAFIX TIBIAL SCREW AND SHEATH
Mitek Worldwide
Orthopedic
91d
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
Cleared
Aug 08, 2003
HBS HEADLESS BONE SCREW
Schoening & Assoc., Inc.
Orthopedic
191d
Cleared
Aug 08, 2003
BIORCI SCREW
Smith & Nephew, Inc.
Orthopedic
18d
Cleared
Jul 14, 2003
PCW PERCUTANEOUS COMPRESSION WIRE
Millennium Medical Technologies, Inc.
Orthopedic
103d
Cleared
Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
Smith & Nephew, Inc.
Orthopedic
29d
Cleared
Jun 26, 2003
MINILOK QUICKANCHOR PLUS
Mitek Worldwide
Orthopedic
87d
Cleared
Jun 26, 2003
RAPIDFIRE SELF DRILLING SCREWS
Walter Lorenz Surgical, Inc.
Orthopedic
21d
Cleared
Jun 19, 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
Inion , Ltd.
Orthopedic
87d
Cleared
Jun 02, 2003
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
Karl Storz Endoscopy
Orthopedic
77d
Cleared
May 30, 2003
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
Inion , Ltd.
Orthopedic
190d
Cleared
Apr 24, 2003
IMPACT SUTURE ANCHOR. MODEL 433510
Bionx Implants, Ltd.
Orthopedic
78d
Cleared
Apr 18, 2003
LEFORTE SYSTEM BONE SCREW
Jeil Medical Corporation
Orthopedic
193d
Cleared
Mar 20, 2003
STRYKER BIOZIP SUTURE ANCHOR
Stryker Endoscopy
Orthopedic
176d
Cleared
Mar 20, 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
KARL STORZ Endoscopy-America, Inc.
Orthopedic
44d
Cleared
Mar 20, 2003
EBI DYNAFIX COMPRESSION BONE SCREW
Ebi, L.P.
Orthopedic
14d
Cleared
Mar 13, 2003
MICROFIX QUICKANCHOR PLUS
Mitek Worldwide
Orthopedic
90d