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
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 19, 1995
GO INTRAMEDULLARY NAIL LOCKING SCREW
Genesis Orthopedics, Inc.
Orthopedic
82d
Cleared
Dec 08, 1995
SUPER SCREW 3.5 MM
Osteomed Corp.
Orthopedic
84d
Cleared
Nov 24, 1995
CORTICELLOUS BONE SCREW
Hayes Medical, Inc.
Orthopedic
141d
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
Cleared
Sep 28, 1995
STRYKER ACL INTERFERENCE SCREW SYSTEM
Stryker Endoscopy
Orthopedic
125d
Cleared
Sep 15, 1995
BIOSCREW ABSORBABLE INTERFERENCE SCREW
Linvatec Corp.
Orthopedic
87d
Cleared
Sep 12, 1995
TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM
Smith & Nephew Richards, Inc.
Orthopedic
91d
Cleared
Aug 25, 1995
EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM
American Medical Electronics, Inc.
Orthopedic
158d
Cleared
Aug 18, 1995
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
Synthes (Usa)
Orthopedic
94d
Cleared
Jul 31, 1995
TI. ALLOY 2.0 MM CORTEX SCREW
Synthes (Usa)
Orthopedic
77d
Cleared
Jul 24, 1995
REUNION BONE SCREW SYSTEM
Smith & Nephew Richards, Inc.
Orthopedic
119d