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).
1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
Cleared
Jan 25, 1996
ARTHREX BIOABSORBABLE INTERFERENCE SCREW
Arthrex, Inc.
Orthopedic
454d
Cleared
Nov 03, 1995
DEPUY STAINLESS STEEL SET SCREW
Depuy, Inc.
Orthopedic
91d
Cleared
Aug 18, 1995
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
Synthes (Usa)
Orthopedic
94d
Cleared
Jul 31, 1995
TI. ALLOY 2.0 MM CORTEX SCREW
Synthes (Usa)
Orthopedic
77d
Cleared
Jul 11, 1995
ABSORBABLE ACETABULAR SCREW
Zimmer, Inc.
Orthopedic
193d
Cleared
Jul 10, 1995
DEPUY SET SCREW
Depuy, Inc.
Orthopedic
136d
Cleared
Jul 03, 1995
HARPOON SUTURE ANCHORS
Biomet, Inc.
Orthopedic
333d
Cleared
Jun 16, 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
Synthes (Usa)
Orthopedic
86d
Cleared
Apr 14, 1995
ARTHREX CANCELLOUS SCREW AND WASHER
Arthrex, Inc.
Orthopedic
161d
Cleared
Feb 02, 1995
BONE MULCH SCREW
Biomet, Inc.
Orthopedic
287d
Cleared
Dec 09, 1994
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
Howmedica Corp.
Orthopedic
102d
Cleared
Oct 19, 1994
AIMS CANNULATED ACL SCREW
Smith & Nephew, Inc.
Orthopedic
89d
Cleared
Aug 01, 1994
ARTHROTEK SET SCREW
Biomet, Inc.
Orthopedic
423d
Cleared
Jul 12, 1994
TITANIUM ALLOY BONE SCREWS
Aesculap, Inc.
Orthopedic
179d
Cleared
Mar 01, 1994
FULLY THREADED ALTA CANCELLOUS BONE SCREW
Howmedica Corp.
Orthopedic
340d
Cleared
Feb 23, 1994
M. KUROSAKA INTERFERENCE FIXATION SCREW
Depuy, Inc.
Orthopedic
204d
Cleared
Feb 23, 1994
ARTHROTEK INTERFERENCE SCREW
Biomet, Inc.
Orthopedic
166d
Cleared
Mar 19, 1993
3.5MM UNIVERSAL COMPRESSION SCREW
Howmedica Corp.
Orthopedic
274d
Cleared
Feb 09, 1993
ARTHREX CANNULATED INTERFERENCE SCREW
Arthrex, Inc.
Orthopedic
435d
Cleared
Feb 11, 1992
UNIVERSAL COMPRESION SCREW
Howmedica Corp.
Orthopedic
90d
Cleared
Jan 24, 1992
M. KUROSAKA(TM) FIXATION SCREW
Depuy, Inc.
Orthopedic
189d
Cleared
Oct 29, 1991
AESCULAP TITANIUM BONE SCREWS
Aesculap, Inc.
Orthopedic
90d
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