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