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
Feb 07, 1994
IMPLEX ACETABULAR CUP SCREW SYSTEM
Implex Corp.
Orthopedic
335d
Cleared
Oct 27, 1993
BONE SCREWS
Instrument Makar, Inc.
Orthopedic
453d
Cleared
Aug 24, 1993
INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR
Acufex Microsurgical, Inc.
Orthopedic
512d
Cleared
Jul 26, 1993
ACUTRACT
Acu Med, Inc.
Orthopedic
159d
Cleared
Apr 06, 1993
TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
Techmedica, Inc.
Orthopedic
133d
Cleared
Apr 01, 1993
M3 LAG SCREW FIXATION SYSTEM
Osteomed Corp.
Orthopedic
233d
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
Oct 13, 1992
ACUFEX FIXATION POST
Acufex Microsurgical, Inc.
Orthopedic
39d
Cleared
Oct 09, 1992
ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW
Alphatec Mfg., Inc.
Orthopedic
99d
Cleared
Aug 06, 1992
ALPHATEC SMALL FRAGMENT SET
Alphatec Mfg., Inc.
Orthopedic
90d
Cleared
Aug 05, 1992
ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW
Alphatec Mfg., Inc.
Orthopedic
79d
Cleared
May 01, 1992
CONCEPT ENDOSTEAL FIXATION DEVICE
Concept, Inc.
Orthopedic
322d
Cleared
Feb 28, 1992
CORTICAL BONE SCREW
Dow Corning Wright
Orthopedic
81d
Cleared
Feb 13, 1992
BONE SCREW 3.5 MM
Acu Med, Inc.
Orthopedic
59d
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
Jan 13, 1992
OREGON FIXATION SCREW
Acu Med, Inc.
Orthopedic
312d
Cleared
Dec 19, 1991
CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW
Techmedica, Inc.
Orthopedic
31d
Cleared
Dec 05, 1991
ALPHATEC CANNULATED BONE SCREWS
Alphatec Mfg., Inc.
Orthopedic
90d
Cleared
Nov 27, 1991
ACE CORTICAL BONE SCREW
Ace Medical Co.
Orthopedic
170d
Cleared
Nov 22, 1991
MAKAR MINI CANNULATED CANCELLOUS SCREWS
Instrument Makar, Inc.
Orthopedic
199d
Cleared
Oct 29, 1991
AESCULAP TITANIUM BONE SCREWS
Aesculap, Inc.
Orthopedic
90d
Cleared
Aug 23, 1991
HUENE FIXATION SCREW
Acu Med, Inc.
Orthopedic
219d