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).
1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
Cleared
Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
Synthes (Usa)
Orthopedic
84d
Cleared
Nov 21, 2001
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
Bionx Implants, Inc.
Orthopedic
28d
Cleared
Nov 20, 2001
RESORBABLE SCREW ANCHOR
Arthrotek, Inc.
Orthopedic
85d
Cleared
Nov 16, 2001
INTEX SCREW
Biomet, Inc.
Orthopedic
87d
Cleared
Sep 06, 2001
MODIFICATION TO THE I.C.O.S SCREW
New Deal, S.A.
Orthopedic
87d
Cleared
Aug 24, 2001
THE SPIN SNAP-OFF SCREW
New Deal, S.A.
Orthopedic
64d
Cleared
Aug 03, 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
Aesculap, Inc.
Orthopedic
114d
Cleared
Jul 13, 2001
IN-FAST BONE SCREW SYSTEM
American Medical Systems, Inc.
Orthopedic
24d
Cleared
Jul 05, 2001
AUTO-DRIVE LAG SCREW SYSTEM
Osteomed Corp.
Orthopedic
97d
Cleared
Jul 02, 2001
PLUS CANCELLOUS BONE SCREWS
Plus Orthopedics
Orthopedic
28d
Cleared
Jun 15, 2001
MODIFICATION TO THE BOLD SCREW
New Deal, S.A.
Orthopedic
51d
Cleared
May 30, 2001
2.0/2.4 CANNULATED SCREW SYSTEM
Osteomed Corp.
Orthopedic
76d
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
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