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
769–792 of 1070
Cleared May 29, 2001
DJ ORTHOPEDICS POST SCREW
K010594
Dj Orthopedics, LLC
Orthopedic · 90d
Cleared May 25, 2001
MENISCUS ARROW SHEATH #CN1000A
K010554
Bionx Implants, Inc.
Orthopedic · 88d
Cleared May 23, 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525
Arthrex, Inc.
Orthopedic · 90d
Cleared May 09, 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633
Mitek Products
Orthopedic · 68d
Cleared May 08, 2001
DJ ORTHOPEDICS INTERFERENCE SCREW
K010595
Dj Orthopedics, LLC
Orthopedic · 69d
Cleared Apr 26, 2001
SMARTSCREW MODEL 222006...227510
K003077
Bionx Implants, Ltd.
Orthopedic · 205d
Cleared Mar 20, 2001
LACTOSORB 5.0 MM WASHER
K001581
Biomet, Inc.
Orthopedic · 302d
Cleared Mar 09, 2001
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM
K003816
Arthrex, Inc.
Orthopedic · 88d
Cleared Mar 07, 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Feb 20, 2001
SYNTHES HAMSTRING LOOP
K003700
Synthes (Usa)
Orthopedic · 81d
Cleared Feb 15, 2001
SMITH & NEPHEW SUTURE ANCHOR
K003599
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Feb 08, 2001
BIOLOK SCREW, BIOSTEON SCREW
K003641
Biocomposites, Ltd.
Orthopedic · 73d
Cleared Sep 22, 2000
HOWMEDICA OSTEONICS SHOULDER SCREW
K002654
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Aug 25, 2000
BIOLOK SCREW
K002070
Biocomposites, Ltd.
Orthopedic · 49d
Cleared Aug 25, 2000
2.4MM CORTEX SCREW, SELF-TAPPING
K002271
Synthes (Usa)
Orthopedic · 30d
Cleared Aug 04, 2000
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K993166
Stryker Endoscopy
Orthopedic · 317d
Cleared Jul 11, 2000
THE KALIX IMPLANT
K001231
New Deal, S.A.
Orthopedic · 85d
Cleared Apr 26, 2000
BIOLOK SCREW
K993630
Encore Orthopedics, Inc.
Orthopedic · 182d
Cleared Apr 03, 2000
ASNIS III CANNULATED SCREW SYSTEM
K000080
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Mar 10, 2000
NONLINEAR TAPER LAG SCREW
K994382
Theken Surgical
Orthopedic · 73d
Cleared Mar 06, 2000
THE LIGAMENT ANCHOR SOFT SCREW
K994152
Corin USA
Orthopedic · 89d
Cleared Feb 25, 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM
K994202
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared Feb 04, 2000
I.CO.S SCREW
K993762
New Deal, S.A.
Orthopedic · 88d
Cleared Feb 03, 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
K000089
Synthes (Usa)
Orthopedic · 22d