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
Jun 28, 1991
UNIVERSAL COMPRESSION SCREW
Howmedica Corp.
Orthopedic
247d
Cleared
Jun 27, 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
Howmedica Corp.
Orthopedic
90d
Cleared
Jan 30, 1991
ACE 3.5MM CORTICAL BONE SCREW
Ace Medical Co.
Orthopedic
83d
Cleared
Jan 04, 1991
U.S. TYPE CRUCIATE SLOT BONE SCREW
O'Tec Corp.
Orthopedic
37d
Cleared
Jan 04, 1991
CORTICAL BONE SCREW (EUROPEAN STYLE)
O'Tec Corp.
Orthopedic
37d
Cleared
Jan 04, 1991
CANCELLOUS SCREW
O'Tec Corp.
Orthopedic
37d
Cleared
Oct 16, 1990
ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW
Ace Medical Co.
Orthopedic
57d
Cleared
Oct 16, 1990
ACE CANNULATED CORTICAL BONE SCREW
Ace Medical Co.
Orthopedic
57d
Cleared
Aug 09, 1990
CANCELLOUS SCREW
Onyx Medical Corp.
Orthopedic
16d
Cleared
Aug 09, 1990
U.S. TYPE CRUCIATE SLOT BONE SCREW
Onyx Medical Corp.
Orthopedic
16d
Cleared
Aug 09, 1990
CORTICAL BONE SCREW (EUROPEAN STYLE)
Onyx Medical Corp.
Orthopedic
16d
Cleared
Aug 09, 1990
HAGIE PIN
Onyx Medical Corp.
Orthopedic
16d
Cleared
Aug 09, 1990
KNOWLES PIN
Onyx Medical Corp.
Orthopedic
16d
Cleared
Jul 30, 1990
LAG SCREW
Onyx Medical Corp.
Orthopedic
6d
Cleared
Jun 20, 1990
CANNULATED INTERFERENCE SCREW SYSTEM
Smith & Nephew Dyonics, Inc.
Orthopedic
75d
Cleared
Mar 28, 1990
ACUFEX STERILE CANNULATED INTERFERENCE SCREW
Acufex Microsurgical, Inc.
Orthopedic
77d
Cleared
Jan 09, 1990
ACUFEX INTERFERENCE SCREW, STERILE
Acufex Microsurgical, Inc.
Orthopedic
106d
Cleared
Dec 06, 1989
EXACTECH BONE SCREW
Exactech, Inc.
Orthopedic
15d
Cleared
Nov 24, 1989
DEPUY (TM) TRUE COMPRESSION SCREW
Depuy, Inc.
Orthopedic
86d
Cleared
Nov 09, 1989
CROSS CANCELLOUS BONE SCREW
Buckman Co., Inc.
Orthopedic
23d
Cleared
Nov 08, 1989
ASNIS II GUIDED BONE SCREW
Howmedica Corp.
Orthopedic
43d
Cleared
Sep 12, 1989
CORTICAL SCREW
Orthopedic Systems, Inc.
Orthopedic
25d
Cleared
Sep 12, 1989
CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM
Orthopedic Systems, Inc.
Orthopedic
25d
Cleared
Sep 12, 1989
CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM
Orthopedic Systems, Inc.
Orthopedic
25d