MRW

FDA Product Code MRW: System, Facet Screw Spinal Device

FDA product code MRW covers facet screw spinal systems used for posterior spinal fixation.

These implants are inserted into the facet joints of the spine to provide segmental stabilization as an alternative or adjunct to pedicle screw fixation. Facet screws offer a less invasive fixation option for selected spinal fusion procedures.

MRW devices are reviewed by the FDA Orthopedic panel.

Leading manufacturers include Providence Medical Technology, Inc., SurGenTec, LLC and Sc Medica.

77
Total
77
Cleared
121d
Avg days
1997
Since
Stable submission activity - 12 submissions in the last 2 years
Consistent review times: 125d avg (recent)

FDA 510(k) Cleared System, Facet Screw Spinal Device Devices (Product Code MRW)

77 devices
1–24 of 77
Cleared May 14, 2026
CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)
K253676
Providence Medical Technology, Inc.
Orthopedic · 174d
Cleared Mar 19, 2026
DiversiVy™ Facet Screw System
K253432
Vy Spine, LLC
Orthopedic · 169d
Cleared Jan 16, 2026
Ion-C
K251714
SurGenTec, LLC
Orthopedic · 227d
Cleared Dec 04, 2025
FFX Facet Fixation System
K250679
Sc Medica
Orthopedic · 273d
Cleared Nov 20, 2025
CORUS-LX Implant
K253190
Providence Medical Technology, Inc.
Orthopedic · 55d
Cleared Oct 16, 2025
FFX Facet Fixation System
K252153
Sc Medica
Orthopedic · 99d
Cleared Jul 10, 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885
Providence Medical Technology, Inc.
Orthopedic · 20d
Cleared May 22, 2025
Arthrex Spine Compression FT Screw
K250920
Arthrex, Inc.
Orthopedic · 56d
Cleared May 21, 2025
The Karma® Fixation System
K242527
Spinal Elements, Inc.
Orthopedic · 268d
Cleared Mar 24, 2025
AERO MIS Facet Fusion System
K243865
Aurora Spine
Orthopedic · 97d
Cleared Dec 04, 2024
Ion 3D
K243265
SurGenTec, LLC
Orthopedic · 50d
Cleared Sep 20, 2024
zLOCK Lumbar Facet Fixation System
K242650
Zygofix , Ltd.
Orthopedic · 16d
Cleared Jun 25, 2024
PMT Posterior Cervical Stabilization System (PCSS)
K241035
Providence Medical Technology, Inc.
Orthopedic · 70d
Cleared Jun 17, 2024
Ion 3D
K241416
SurGenTec, LLC
Orthopedic · 31d
Cleared May 09, 2024
SC Medica FFX
K232468
Sc Medica
Orthopedic · 268d
Cleared Apr 18, 2024
zLOCK Lumbar Facet Fixation System
K240085
Zygofix , Ltd.
Orthopedic · 98d
Cleared Feb 08, 2024
Ion 3D
K240086
SurGenTec, LLC
Orthopedic · 28d
Cleared Dec 19, 2023
PMT Facet Fixation System, Lumbar (PMT FFS-LX)
K230840
Providence Medical Technology, Inc.
Orthopedic · 267d
Cleared Dec 13, 2023
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System
K232877
K&J Consulting Corporation
Orthopedic · 89d
Cleared Aug 11, 2023
PMT Expandable Cage (PMT EXP)
K230297
Providence Medical Technology, Inc.
Orthopedic · 190d
Cleared Dec 09, 2022
PMT Facet Fixation System (PMT FFS)
K220951
Providence Medical Technology, Inc.
Orthopedic · 252d
Cleared Oct 05, 2022
FaSet Fixation System
K222515
Dio Medical Corporation
Orthopedic · 47d
Cleared Feb 25, 2022
Ion Facet Screw System
K211855
SurGenTec, LLC
Orthopedic · 254d
Cleared Dec 16, 2019
CORRIDOR Fixation System
K192744
Globus Medical, Inc.
Orthopedic · 77d

About Product Code MRW - Regulatory Context

510(k) Submission Activity

77 total 510(k) submissions under product code MRW since 1997, with 77 receiving FDA clearance (average review time: 121 days).

Submission volume has remained relatively stable over the observed period, with 12 submissions in the last 24 months.

FDA 510(k) Review Time - MRW Product Code

FDA review times for MRW submissions have been consistent, averaging 125 days recently vs 120 days historically.

MRW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →