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
793–816 of 1064
Cleared Sep 20, 1996
SCARF THREAD-HEAD SCREW
K962236
Landos, Inc.
Orthopedic · 101d
Cleared Aug 23, 1996
COMPRESSION SCREW
K962779
Orthopaedic Biosystems, Ltd.
Orthopedic · 37d
Cleared Aug 19, 1996
INTERFERENCE SCREW
K960962
Linvatec Corp.
Orthopedic · 161d
Cleared Aug 15, 1996
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960940
Linvatec Corp.
Orthopedic · 160d
Cleared Aug 07, 1996
SYNTHES ANATOMICAL LOCKING PLATE SYSTEM
K961413
Synthes (Usa)
Orthopedic · 117d
Cleared Aug 06, 1996
MEDICINELODGE, INC. SET SCREW
K961905
Medicinelodge, Inc.
Orthopedic · 82d
Cleared Aug 05, 1996
SYNTHES 7.0/7.3 MM CANNULATED SCREWS
K962011
Synthes (Usa)
Orthopedic · 74d
Cleared Jul 23, 1996
SUBTALAR MBA SYSTEM
K960692
Kinetikos Medical, Inc.
Orthopedic · 154d
Cleared Jul 16, 1996
ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER
K961649
Smith & Nephew Endoscopy, Inc.
Orthopedic · 77d
Cleared Jun 19, 1996
DEPUY ADVANTAGE FIXATION SCREW SYSTEM
K961234
Depuy, Inc.
Orthopedic · 82d
Cleared Jun 06, 1996
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
K960704
Depuy, Inc.
Orthopedic · 118d
Cleared May 17, 1996
WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW
K961157
Whiteside Biomechanics, Inc.
Orthopedic · 56d
Cleared Mar 25, 1996
K3 BONE SCREW SYSTEM
K960533
Kinetikos Medical, Inc.
Orthopedic · 47d
Cleared Mar 25, 1996
K2 BONE SCREW SYSTEM
K960537
Kinetikos Medical, Inc.
Orthopedic · 47d
Cleared Mar 22, 1996
NORTHO BONE SCREW
K925872
Northo Orthopedics
Orthopedic · 1219d
Cleared Mar 04, 1996
J.B.S. T.T.A SCREW
K955710
J.B.S. (Usa), Inc.
Orthopedic · 81d
Cleared Mar 04, 1996
CANNULATED PLUS HIP SCREW (STERILE)
K955837
Wrightmedicaltechnologyinc
Orthopedic · 69d
Cleared Feb 15, 1996
ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
K954246
Acufex Microsurgical, Inc.
Orthopedic · 157d
Cleared Jan 30, 1996
MLI INTERFERENCE SCREW
K953350
Medicinelodge, Inc.
Orthopedic · 197d
Cleared Jan 25, 1996
ARTHREX BIOABSORBABLE INTERFERENCE SCREW
K945303
Arthrex, Inc.
Orthopedic · 454d
Cleared Jan 25, 1996
FIXANO D.D.S. (DOUBLE SLIDING SCREW)
K954757
Ferguson Medical
Orthopedic · 101d
Cleared Dec 08, 1995
SUPER SCREW 3.5 MM
K954330
Osteomed Corp.
Orthopedic · 84d
Cleared Nov 03, 1995
DEPUY STAINLESS STEEL SET SCREW
K953650
Depuy, Inc.
Orthopedic · 91d
Cleared Oct 31, 1995
6.5MM SOLID CANCELLOUS BONE SCREW
K954485
Ace Medical Co.
Orthopedic · 34d