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