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., Wrightmedicaltechnologyinc and Synthes (Usa).

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
193–216 of 1070
Cleared Nov 23, 2018
HammerTechTM Fixation System
K182684
Fusion Orthopedics, LLC
Orthopedic · 58d
Cleared Nov 21, 2018
DePuy Synthes 2.0 mm Quick Insertion Screws
K180541
Synthes USA Products, LLC
Orthopedic · 265d
Cleared Oct 26, 2018
Two-Step Implant System
K181898
Trilliant Surgical
Orthopedic · 102d
Cleared Sep 07, 2018
SILVERBACK Gorilla Plating System
K182148
Paragon 28, Inc.
Orthopedic · 30d
Cleared Jul 17, 2018
Field Orthopaedics Micro Screw System
K180348
Field Orthopaedics Pty, Ltd.
Orthopedic · 159d
Cleared Jul 13, 2018
Injection Screw
K173556
Biedermann Medtech, Inc.
Orthopedic · 238d
Cleared Jul 11, 2018
SALVATION Midfoot Nail
K180024
Wrightmedicaltechnologyinc
Orthopedic · 189d
Cleared Jun 20, 2018
Fracture and Correction System
K180377
In2bones USA, LLC
Orthopedic · 128d
Cleared Jun 04, 2018
VariAx 2 System
K180500
Stryker GmbH
Orthopedic · 98d
Cleared May 09, 2018
Diamond Orthopedic Bone Fixation Screws and Pins
K180932
Diamond Orthopedic, LLC
Orthopedic · 29d
Cleared Apr 25, 2018
InCore® Lapidus System
K180257
Nextremity Solutions, Inc.
Orthopedic · 85d
Cleared Apr 20, 2018
SafetyFix EasyOut System
K180753
Safetyfix Medical Technologies, Inc.
Orthopedic · 29d
Cleared Feb 12, 2018
MotoBAND CP Implant System
K173710
Crossroads Extremity Systems, LLC
Orthopedic · 70d
Cleared Feb 07, 2018
G-Beam Fusion Beaming System
K172698
Orthofix Srl
Orthopedic · 153d
Cleared Jan 12, 2018
HBS2 Headless Bone Screw
K171628
Stuckenbrock Medizintechnik GmbH
Orthopedic · 224d
Cleared Dec 22, 2017
Arthrosurface Bone Screws
K172383
Arthrosurface, Inc.
Orthopedic · 136d
Cleared Dec 14, 2017
Cannulated Screw Internal Fixation System
K173286
Life Spine, Inc.
Orthopedic · 59d
Cleared Nov 28, 2017
PIT’Stop® implant
K170688
In2bones Sas
Orthopedic · 266d
Cleared Nov 27, 2017
VariAx 2 System
K173135
Stryker GmbH
Orthopedic · 59d
Cleared Oct 25, 2017
Treace Medical Concepts (TMC) Compression Screw System
K172617
Treace Medical Concepts, Inc.
Orthopedic · 55d
Cleared Oct 23, 2017
IRENE Cannulated Screw System
K170056
Tianjin Zhengtian Medical Instrument Co., Ltd.
Orthopedic · 290d
Cleared Oct 23, 2017
MECRON Cannulated Screw System
K172213
Merete GmbH
Orthopedic · 91d
Cleared Oct 02, 2017
Large Screws Range
K172596
Newclip Technics
Orthopedic · 34d
Cleared Sep 14, 2017
BePOD® Foot Screws
K163148
Fournitures Hospitalieres Industrie
Orthopedic · 309d