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