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).

1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
49–72 of 1059
Cleared Sep 05, 2023
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
K231819
Innovate Orthopaedics Limited
Orthopedic · 76d
Cleared Aug 30, 2023
Nexis® compressive screws
K223468
Novastep
Orthopedic · 286d
Cleared Jul 27, 2023
IBS-B MIS Beveled Screw System
K231236
In2bones USA, LLC
Orthopedic · 90d
Cleared Jul 18, 2023
Forma Medical Headless Compression Screw
K230945
Forma Medical, Inc.
Orthopedic · 105d
Cleared Jun 29, 2023
OsteoCentric ACL Fixation System
K230595
OsteoCentric Technologies
Orthopedic · 118d
Cleared Jun 26, 2023
Bone Bolt System
K230867
University of Utah, Department of Orthopaedics
Orthopedic · 89d
Cleared Jun 12, 2023
Cut Screw - Percutaneous Compression Screw
K230397
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 118d
Cleared Jun 09, 2023
Acumed Acutrak 3 Headless Compression Screw System
K230744
Acumed, LLC
Orthopedic · 84d
Cleared Apr 28, 2023
Hand Trauma Threaded Nail System
K230908
Skeletal Dynamics, Inc.
Orthopedic · 28d
Cleared Apr 19, 2023
SimpliFix Hip System
K230053
Stabiliz Orthopaedics, Inc.
Orthopedic · 103d
Cleared Apr 17, 2023
TriMed Threaded Intramedullary Nail System
K230749
TriMed, Inc.
Orthopedic · 31d
Cleared Feb 28, 2023
REVCON (TM) Screw System
K223392
Voom Medical Devices, Inc.
Orthopedic · 112d
Cleared Feb 17, 2023
PROstep(TM) MIS 5mm Chamfer Screw System
K221645
Wright Medical Technology
Orthopedic · 256d
Cleared Feb 16, 2023
Bony Trauma Extremity System (BTES) Screw Range, NX Nail
K230118
Field Orthopaedics Pty, Ltd.
Orthopedic · 30d
Cleared Feb 13, 2023
OIC Intramedullary Screw System
K223761
Orthopaedic Implant Company
Orthopedic · 60d
Cleared Jan 25, 2023
CREED™ Cannulated Screws
K223847
Glw, Inc.
Orthopedic · 34d
Cleared Jan 10, 2023
Metal Cannulated Screw
K221090
Double Medical Technology, Inc.
Orthopedic · 272d
Cleared Jan 10, 2023
Haymaker® Screw System
K222799
Orthocircle Spine D.B.A. OC Medical Devices
Orthopedic · 116d
Cleared Dec 29, 2022
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
K221333
Acumed, LLC
Orthopedic · 234d
Cleared Dec 23, 2022
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
K221193
OSSIO , Ltd.
Orthopedic · 242d
Cleared Dec 16, 2022
BRM TOOL Screws, BIOPLAN Subtalar Implant
K222820
Brm Extremities
Orthopedic · 88d
Cleared Dec 16, 2022
Phantom Metatarsal Shortening System
K223184
Paragon 28, Inc.
Orthopedic · 65d
Cleared Dec 13, 2022
REDEMPTION Beaming System
K221342
Vilex, LLC
Orthopedic · 218d
Cleared Dec 12, 2022
Metal Bone Screw
K220921
Double Medical Technology, Inc.
Orthopedic · 257d