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).

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
673–696 of 1070
Cleared Oct 22, 2003
STS SCREW
K032682
Ortho-Pro, LLC
Orthopedic · 54d
Cleared Oct 15, 2003
BIO-INTRAFIX TIBIAL SCREW AND SHEATH
K032167
Mitek Worldwide
Orthopedic · 91d
Cleared Oct 08, 2003
ENDOTINE FOREHEAD DEVICE
K032770
Coapt Systems, Inc.
Orthopedic · 30d
Cleared Oct 07, 2003
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B
K032098
Arthrex, Inc.
Orthopedic · 91d
Cleared Oct 01, 2003
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE
K032072
Arthrotek, Inc.
Orthopedic · 90d
Cleared Sep 22, 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
K031945
Arthrex, Inc.
Orthopedic · 90d
Cleared Sep 04, 2003
ALANTECH GRAFT FIXATION SCREW
K031937
Arthrocare Corp.
Orthopedic · 73d
Cleared Aug 22, 2003
OSTEOMED SUBTALAR IMPLANT SYSTEM
K031155
Osteomed LP
Orthopedic · 133d
Cleared Aug 11, 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Aug 08, 2003
HBS HEADLESS BONE SCREW
K030302
Schoening & Assoc., Inc.
Orthopedic · 191d
Cleared Aug 08, 2003
BIORCI SCREW
K032224
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Jul 14, 2003
PCW PERCUTANEOUS COMPRESSION WIRE
K031050
Millennium Medical Technologies, Inc.
Orthopedic · 103d
Cleared Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Jun 26, 2003
MINILOK QUICKANCHOR PLUS
K030995
Mitek Worldwide
Orthopedic · 87d
Cleared Jun 26, 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Jun 19, 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K030900
Inion , Ltd.
Orthopedic · 87d
Cleared Jun 02, 2003
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K030848
Karl Storz Endoscopy
Orthopedic · 77d
Cleared May 30, 2003
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K023887
Inion , Ltd.
Orthopedic · 190d
Cleared Apr 24, 2003
IMPACT SUTURE ANCHOR. MODEL 433510
K030388
Bionx Implants, Ltd.
Orthopedic · 78d
Cleared Apr 18, 2003
LEFORTE SYSTEM BONE SCREW
K023365
Jeil Medical Corporation
Orthopedic · 193d
Cleared Mar 20, 2003
STRYKER BIOZIP SUTURE ANCHOR
K023192
Stryker Endoscopy
Orthopedic · 176d
Cleared Mar 20, 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 44d
Cleared Mar 20, 2003
EBI DYNAFIX COMPRESSION BONE SCREW
K030706
Ebi, L.P.
Orthopedic · 14d
Cleared Mar 13, 2003
MICROFIX QUICKANCHOR PLUS
K024115
Mitek Worldwide
Orthopedic · 90d