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).
1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
Cleared
Jul 18, 1995
NEXMED CANCELLOUS BONE SCREWS
Nexmed, Inc.
Orthopedic
99d
Cleared
Jul 11, 1995
ANSPACH SUTURE ANCHOR
The Anspach Effort, Inc.
Orthopedic
243d
Cleared
Jul 11, 1995
ABSORBABLE ACETABULAR SCREW
Zimmer, Inc.
Orthopedic
193d
Cleared
Jul 11, 1995
OGDEN ANCHOR
American Medical Electronics, Inc.
Orthopedic
133d
Cleared
Jul 10, 1995
DEPUY SET SCREW
Depuy, Inc.
Orthopedic
136d
Cleared
Jul 05, 1995
ORTHOPEDIC SCREW FIXATION
Osteomed Corp.
Orthopedic
782d
Cleared
Jul 03, 1995
HARPOON SUTURE ANCHORS
Biomet, Inc.
Orthopedic
333d
Cleared
Jul 03, 1995
LMT BONE ANCHOR
Li Medical Technologies, Inc.
Orthopedic
105d
Cleared
Jul 03, 1995
LMT BONE ANCHOR
Li Medical Technologies, Inc.
Orthopedic
95d
Cleared
Jul 03, 1995
OGDEN ANCHOR
American Medical Electronics, Inc.
Orthopedic
94d
Cleared
Jul 03, 1995
OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS
American Medical Electronics, Inc.
Orthopedic
95d
Cleared
Jun 30, 1995
K4 BONE SCREW SYSTEM
Kinetikos Medical, Inc.
Orthopedic
135d
Cleared
Jun 27, 1995
SFC
Medpac
Orthopedic
97d
Cleared
Jun 22, 1995
ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW
Smith and Nephew Donjoy, Inc.
Orthopedic
213d
Cleared
Jun 22, 1995
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
Osteotech, Inc.
Orthopedic
129d
Cleared
Jun 16, 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
Synthes (Usa)
Orthopedic
86d
Cleared
Jun 14, 1995
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
Smith & Nephew Richards, Inc.
Orthopedic
628d
Cleared
May 17, 1995
MED-SURG SUTURE WASHER
Medical Surgical, Inc.
Orthopedic
114d
Cleared
May 10, 1995
LINVATEC STASYS-PES FIXATION DEVICE
Linvatec Corp.
Orthopedic
614d
Cleared
May 05, 1995
ACUTRAK PLUS FIXATION SYSTEM
Acu Med, Inc.
Orthopedic
241d
Cleared
Apr 14, 1995
ARTHREX CANCELLOUS SCREW AND WASHER
Arthrex, Inc.
Orthopedic
161d
Cleared
Feb 03, 1995
AIMS CANNULATED ACL SCREW (7MM DIAMETER)
Smith and Nephew Donjoy, Inc.
Orthopedic
99d
Cleared
Feb 02, 1995
BONE MULCH SCREW
Biomet, Inc.
Orthopedic
287d
Cleared
Jan 24, 1995
DYONICS FIXATION SCREWS
Smith & Nephew Dyonics, Inc.
Orthopedic
92d