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
Sep 11, 1989
OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
Osteonics Corp.
Orthopedic
91d
Cleared
Aug 21, 1989
DEPUY CANNULATED BONE SCREW
Depuy, Inc.
Orthopedic
108d
Cleared
Aug 07, 1989
VECSEI EXPANDING SCREW
Howmedica Corp.
Orthopedic
108d
Cleared
Jun 22, 1989
REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW
Ace Medical Co.
Orthopedic
80d
Cleared
Oct 12, 1988
ACUFEX INTERFERENCE SCREW AND SCREWDRIVER
Acufex Microsurgical, Inc.
Orthopedic
27d
Cleared
Aug 01, 1988
ACE CANCELLOUS BONE SCREW
Buckman Co., Inc.
Orthopedic
24d
Cleared
Mar 07, 1988
INTERFERENCE SCREW
Concept, Inc.
Orthopedic
115d
Cleared
Jan 20, 1988
ACROMED CANCELLOUS BONE SCREW
Buckman Co., Inc.
Orthopedic
42d
Cleared
Jan 07, 1988
ORTHOMET BONE SCREWS
Orthomet, Inc.
Orthopedic
30d
Cleared
Dec 17, 1987
ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW
Buckman Co., Inc.
Orthopedic
34d
Cleared
Dec 11, 1987
ACE CORTICAL LAG SCREW
Buckman Co., Inc.
Orthopedic
28d
Cleared
Dec 07, 1987
TITANIUM BONE SCREWS
Orthopedic Systems, Inc.
Orthopedic
55d
Cleared
Nov 24, 1987
ACE SELFTAPPING CANCELLOUS BONE SCREW
Ace Medical Co.
Orthopedic
15d
Cleared
Sep 18, 1987
OMNIFIT BONE SCREW
Osteonics Corp.
Orthopedic
32d
Cleared
Aug 17, 1987
ACE CANCELLOUS BONE SCREW
Ace Medical Co.
Orthopedic
27d
Cleared
Jul 30, 1987
CORTICAL BONE SCREWS
Military Engineering, Inc.
Orthopedic
20d
Cleared
Jul 21, 1987
CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM
Concept, Inc.
Orthopedic
47d
Cleared
Mar 25, 1987
CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW
Concept, Inc.
Orthopedic
8d
Cleared
Feb 03, 1987
URESIL T-SYSTEM BONE SCREWS
Uresil Corp.
Orthopedic
21d
Cleared
Dec 18, 1986
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
Howmedica Corp.
Orthopedic
23d
Cleared
Dec 15, 1986
CANCELLOUS BONE SCREW
Dow Corning Wright
Orthopedic
20d
Cleared
Aug 29, 1986
WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW
Buckman Co., Inc.
Orthopedic
79d
Cleared
Feb 07, 1986
ACROMED CANCELLOUS BONE SCREW
Buckman Co., Inc.
Orthopedic
35d
Cleared
Jan 21, 1986
MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P
Advanced Biosearch Assn.
Orthopedic
36d