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., Synthes (Usa) and Wrightmedicaltechnologyinc.

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
745–768 of 1070
Cleared Dec 11, 2001
SURGICAL DYNAMICS MENISCAL STAPLE
K013890
United States Surgical, A Division of Tyco Healthc
Orthopedic · 18d
Cleared Dec 10, 2001
REUNITE FUSION SCREW
K011451
Biomet, Inc.
Orthopedic · 213d
Cleared Dec 03, 2001
RESORBABLE NO PROFILE SCREW AND WASHER
K012469
Biomet Manufacturing, Inc.
Orthopedic · 123d
Cleared Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
K012572
Biomet, Inc.
Orthopedic · 116d
Cleared Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945
Synthes (Usa)
Orthopedic · 90d
Cleared Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044
Synthes (Usa)
Orthopedic · 84d
Cleared Nov 21, 2001
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
K013546
Bionx Implants, Inc.
Orthopedic · 28d
Cleared Nov 20, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
K012817
Triage Medical, Inc.
Orthopedic · 90d
Cleared Nov 20, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
K012818
Triage Medical, Inc.
Orthopedic · 90d
Cleared Nov 20, 2001
RESORBABLE SCREW ANCHOR
K012872
Arthrotek, Inc.
Orthopedic · 85d
Cleared Nov 16, 2001
INTEX SCREW
K012798
Biomet, Inc.
Orthopedic · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE I.C.O.S SCREW
K011821
New Deal, S.A.
Orthopedic · 87d
Cleared Aug 24, 2001
THE SPIN SNAP-OFF SCREW
K011946
New Deal, S.A.
Orthopedic · 64d
Cleared Aug 17, 2001
TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
K012280
Triage Medical, Inc.
Orthopedic · 29d
Cleared Aug 03, 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102
Aesculap, Inc.
Orthopedic · 114d
Cleared Aug 01, 2001
CANNULATED PLUS SCREW SYSTEM
K010738
Orthomatrix, Inc.
Orthopedic · 142d
Cleared Jul 18, 2001
1.5MM BONE FIXATION KIT
K012000
Bionx Implants, Ltd.
Orthopedic · 21d
Cleared Jul 18, 2001
SMARTSCREW
K012001
Bionx Implants, Ltd.
Orthopedic · 21d
Cleared Jul 13, 2001
IN-FAST BONE SCREW SYSTEM
K011910
American Medical Systems, Inc.
Orthopedic · 24d
Cleared Jul 05, 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964
Osteomed Corp.
Orthopedic · 97d
Cleared Jul 02, 2001
PLUS CANCELLOUS BONE SCREWS
K011719
Plus Orthopedics
Orthopedic · 28d
Cleared Jun 20, 2001
TITANIUM COMPRESSION ANCHOR SYSTEM
K010884
Anchor Medical Technologies
Orthopedic · 89d
Cleared Jun 15, 2001
MODIFICATION TO THE BOLD SCREW
K011262
New Deal, S.A.
Orthopedic · 51d
Cleared May 30, 2001
2.0/2.4 CANNULATED SCREW SYSTEM
K010783
Osteomed Corp.
Orthopedic · 76d