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
865–888 of 1064
Cleared Feb 07, 1994
IMPLEX ACETABULAR CUP SCREW SYSTEM
K931187
Implex Corp.
Orthopedic · 335d
Cleared Oct 27, 1993
BONE SCREWS
K923841
Instrument Makar, Inc.
Orthopedic · 453d
Cleared Aug 24, 1993
INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR
K921481
Acufex Microsurgical, Inc.
Orthopedic · 512d
Cleared Jul 26, 1993
ACUTRACT
K930834
Acu Med, Inc.
Orthopedic · 159d
Cleared Apr 06, 1993
TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
K926579
Techmedica, Inc.
Orthopedic · 133d
Cleared Apr 01, 1993
M3 LAG SCREW FIXATION SYSTEM
K924018
Osteomed Corp.
Orthopedic · 233d
Cleared Mar 19, 1993
3.5MM UNIVERSAL COMPRESSION SCREW
K923477
Howmedica Corp.
Orthopedic · 274d
Cleared Feb 09, 1993
ARTHREX CANNULATED INTERFERENCE SCREW
K915424
Arthrex, Inc.
Orthopedic · 435d
Cleared Oct 13, 1992
ACUFEX FIXATION POST
K924514
Acufex Microsurgical, Inc.
Orthopedic · 39d
Cleared Oct 09, 1992
ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW
K923256
Alphatec Mfg., Inc.
Orthopedic · 99d
Cleared Aug 06, 1992
ALPHATEC SMALL FRAGMENT SET
K922166
Alphatec Mfg., Inc.
Orthopedic · 90d
Cleared Aug 05, 1992
ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW
K922322
Alphatec Mfg., Inc.
Orthopedic · 79d
Cleared May 01, 1992
CONCEPT ENDOSTEAL FIXATION DEVICE
K912640
Concept, Inc.
Orthopedic · 322d
Cleared Feb 28, 1992
CORTICAL BONE SCREW
K915448
Dow Corning Wright
Orthopedic · 81d
Cleared Feb 13, 1992
BONE SCREW 3.5 MM
K915613
Acu Med, Inc.
Orthopedic · 59d
Cleared Feb 11, 1992
UNIVERSAL COMPRESION SCREW
K915124
Howmedica Corp.
Orthopedic · 90d
Cleared Jan 24, 1992
M. KUROSAKA(TM) FIXATION SCREW
K913210
Depuy, Inc.
Orthopedic · 189d
Cleared Jan 13, 1992
OREGON FIXATION SCREW
K910976
Acu Med, Inc.
Orthopedic · 312d
Cleared Dec 19, 1991
CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW
K915187
Techmedica, Inc.
Orthopedic · 31d
Cleared Dec 05, 1991
ALPHATEC CANNULATED BONE SCREWS
K914004
Alphatec Mfg., Inc.
Orthopedic · 90d
Cleared Nov 27, 1991
ACE CORTICAL BONE SCREW
K912598
Ace Medical Co.
Orthopedic · 170d
Cleared Nov 22, 1991
MAKAR MINI CANNULATED CANCELLOUS SCREWS
K912021
Instrument Makar, Inc.
Orthopedic · 199d
Cleared Oct 29, 1991
AESCULAP TITANIUM BONE SCREWS
K913415
Aesculap, Inc.
Orthopedic · 90d
Cleared Aug 23, 1991
HUENE FIXATION SCREW
K910193
Acu Med, Inc.
Orthopedic · 219d