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
889–912 of 1070
Cleared Jun 19, 1996
DEPUY ADVANTAGE FIXATION SCREW SYSTEM
K961234
Depuy, Inc.
Orthopedic · 82d
Cleared Jun 06, 1996
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
K960704
Depuy, Inc.
Orthopedic · 118d
Cleared May 17, 1996
WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW
K961157
Whiteside Biomechanics, Inc.
Orthopedic · 56d
Cleared Mar 25, 1996
K3 BONE SCREW SYSTEM
K960533
Kinetikos Medical, Inc.
Orthopedic · 47d
Cleared Mar 25, 1996
K2 BONE SCREW SYSTEM
K960537
Kinetikos Medical, Inc.
Orthopedic · 47d
Cleared Mar 22, 1996
NORTHO BONE SCREW
K925872
Northo Orthopedics
Orthopedic · 1219d
Cleared Mar 04, 1996
J.B.S. T.T.A SCREW
K955710
J.B.S. (Usa), Inc.
Orthopedic · 81d
Cleared Mar 04, 1996
CANNULATED PLUS HIP SCREW (STERILE)
K955837
Wrightmedicaltechnologyinc
Orthopedic · 69d
Cleared Feb 15, 1996
ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
K954246
Acufex Microsurgical, Inc.
Orthopedic · 157d
Cleared Jan 30, 1996
MLI INTERFERENCE SCREW
K953350
Medicinelodge, Inc.
Orthopedic · 197d
Cleared Jan 25, 1996
ARTHREX BIOABSORBABLE INTERFERENCE SCREW
K945303
Arthrex, Inc.
Orthopedic · 454d
Cleared Jan 25, 1996
FIXANO D.D.S. (DOUBLE SLIDING SCREW)
K954757
Ferguson Medical
Orthopedic · 101d
Cleared Dec 19, 1995
GO INTRAMEDULLARY NAIL LOCKING SCREW
K954511
Genesis Orthopedics, Inc.
Orthopedic · 82d
Cleared Dec 08, 1995
SUPER SCREW 3.5 MM
K954330
Osteomed Corp.
Orthopedic · 84d
Cleared Nov 24, 1995
CORTICELLOUS BONE SCREW
K953198
Hayes Medical, Inc.
Orthopedic · 141d
Cleared Nov 03, 1995
DEPUY STAINLESS STEEL SET SCREW
K953650
Depuy, Inc.
Orthopedic · 91d
Cleared Oct 31, 1995
6.5MM SOLID CANCELLOUS BONE SCREW
K954485
Ace Medical Co.
Orthopedic · 34d
Cleared Sep 28, 1995
STRYKER ACL INTERFERENCE SCREW SYSTEM
K952460
Stryker Endoscopy
Orthopedic · 125d
Cleared Sep 15, 1995
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K952831
Linvatec Corp.
Orthopedic · 87d
Cleared Sep 12, 1995
TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM
K952697
Smith & Nephew Richards, Inc.
Orthopedic · 91d
Cleared Aug 25, 1995
EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM
K951232
American Medical Electronics, Inc.
Orthopedic · 158d
Cleared Aug 18, 1995
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
K952296
Synthes (Usa)
Orthopedic · 94d
Cleared Jul 31, 1995
TI. ALLOY 2.0 MM CORTEX SCREW
K952272
Synthes (Usa)
Orthopedic · 77d
Cleared Jul 24, 1995
REUNION BONE SCREW SYSTEM
K951389
Smith & Nephew Richards, Inc.
Orthopedic · 119d