HWC · Class II · 21 CFR 888.3040

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
913–936 of 1064
Cleared Sep 11, 1989
OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
K894124
Osteonics Corp.
Orthopedic · 91d
Cleared Aug 21, 1989
DEPUY CANNULATED BONE SCREW
K893512
Depuy, Inc.
Orthopedic · 108d
Cleared Aug 07, 1989
VECSEI EXPANDING SCREW
K892925
Howmedica Corp.
Orthopedic · 108d
Cleared Jun 22, 1989
REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW
K892214
Ace Medical Co.
Orthopedic · 80d
Cleared Oct 12, 1988
ACUFEX INTERFERENCE SCREW AND SCREWDRIVER
K883910
Acufex Microsurgical, Inc.
Orthopedic · 27d
Cleared Aug 01, 1988
ACE CANCELLOUS BONE SCREW
K882831
Buckman Co., Inc.
Orthopedic · 24d
Cleared Mar 07, 1988
INTERFERENCE SCREW
K874676
Concept, Inc.
Orthopedic · 115d
Cleared Jan 20, 1988
ACROMED CANCELLOUS BONE SCREW
K875053
Buckman Co., Inc.
Orthopedic · 42d
Cleared Jan 07, 1988
ORTHOMET BONE SCREWS
K875050
Orthomet, Inc.
Orthopedic · 30d
Cleared Dec 17, 1987
ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW
K874670
Buckman Co., Inc.
Orthopedic · 34d
Cleared Dec 11, 1987
ACE CORTICAL LAG SCREW
K874672
Buckman Co., Inc.
Orthopedic · 28d
Cleared Dec 07, 1987
TITANIUM BONE SCREWS
K874130
Orthopedic Systems, Inc.
Orthopedic · 55d
Cleared Nov 24, 1987
ACE SELFTAPPING CANCELLOUS BONE SCREW
K874593
Ace Medical Co.
Orthopedic · 15d
Cleared Sep 18, 1987
OMNIFIT BONE SCREW
K873251
Osteonics Corp.
Orthopedic · 32d
Cleared Aug 17, 1987
ACE CANCELLOUS BONE SCREW
K872859
Ace Medical Co.
Orthopedic · 27d
Cleared Jul 30, 1987
CORTICAL BONE SCREWS
K872738
Military Engineering, Inc.
Orthopedic · 20d
Cleared Jul 21, 1987
CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM
K872156
Concept, Inc.
Orthopedic · 47d
Cleared Mar 25, 1987
CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW
K871037
Concept, Inc.
Orthopedic · 8d
Cleared Feb 03, 1987
URESIL T-SYSTEM BONE SCREWS
K870141
Uresil Corp.
Orthopedic · 21d
Cleared Dec 18, 1986
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
K864633
Howmedica Corp.
Orthopedic · 23d
Cleared Dec 15, 1986
CANCELLOUS BONE SCREW
K864626
Dow Corning Wright
Orthopedic · 20d
Cleared Aug 29, 1986
WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW
K862230
Buckman Co., Inc.
Orthopedic · 79d
Cleared Feb 07, 1986
ACROMED CANCELLOUS BONE SCREW
K860017
Buckman Co., Inc.
Orthopedic · 35d
Cleared Jan 21, 1986
MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P
K855031
Advanced Biosearch Assn.
Orthopedic · 36d