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).

1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
361–384 of 1059
Cleared Jan 25, 1996
ARTHREX BIOABSORBABLE INTERFERENCE SCREW
K945303
Arthrex, Inc.
Orthopedic · 454d
Cleared Nov 03, 1995
DEPUY STAINLESS STEEL SET SCREW
K953650
Depuy, Inc.
Orthopedic · 91d
Cleared Aug 18, 1995
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
K952296
Synthes (Usa)
Orthopedic · 94d
Cleared Jul 31, 1995
TI. ALLOY 2.0 MM CORTEX SCREW
K952272
Synthes (Usa)
Orthopedic · 77d
Cleared Jul 11, 1995
ABSORBABLE ACETABULAR SCREW
K946347
Zimmer, Inc.
Orthopedic · 193d
Cleared Jul 10, 1995
DEPUY SET SCREW
K950833
Depuy, Inc.
Orthopedic · 136d
Cleared Jul 03, 1995
HARPOON SUTURE ANCHORS
K943806
Biomet, Inc.
Orthopedic · 333d
Cleared Jun 16, 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304
Synthes (Usa)
Orthopedic · 86d
Cleared Apr 14, 1995
ARTHREX CANCELLOUS SCREW AND WASHER
K945426
Arthrex, Inc.
Orthopedic · 161d
Cleared Feb 02, 1995
BONE MULCH SCREW
K941941
Biomet, Inc.
Orthopedic · 287d
Cleared Dec 09, 1994
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213
Howmedica Corp.
Orthopedic · 102d
Cleared Oct 19, 1994
AIMS CANNULATED ACL SCREW
K943539
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Aug 01, 1994
ARTHROTEK SET SCREW
K932721
Biomet, Inc.
Orthopedic · 423d
Cleared Jul 12, 1994
TITANIUM ALLOY BONE SCREWS
K940207
Aesculap, Inc.
Orthopedic · 179d
Cleared Mar 01, 1994
FULLY THREADED ALTA CANCELLOUS BONE SCREW
K931524
Howmedica Corp.
Orthopedic · 340d
Cleared Feb 23, 1994
M. KUROSAKA INTERFERENCE FIXATION SCREW
K933738
Depuy, Inc.
Orthopedic · 204d
Cleared Feb 23, 1994
ARTHROTEK INTERFERENCE SCREW
K934469
Biomet, Inc.
Orthopedic · 166d
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 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 Oct 29, 1991
AESCULAP TITANIUM BONE SCREWS
K913415
Aesculap, Inc.
Orthopedic · 90d
Cleared Jun 28, 1991
UNIVERSAL COMPRESSION SCREW
K904809
Howmedica Corp.
Orthopedic · 247d
Cleared Jun 27, 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398
Howmedica Corp.
Orthopedic · 90d