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 Nuvasive, Inc..
78
Total
78
Cleared
120d
Avg days
1997
Since
Growing category -
13 submissions in the last 2 years
vs 10 in the prior period
Consistent review times:
120d avg (recent)
FDA 510(k) Cleared System, Facet Screw Spinal Device Devices (Product Code MRW)
78 devices
Cleared
May 14, 2026
CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)
Providence Medical Technology, Inc.
Orthopedic
174d
Cleared
Mar 19, 2026
DiversiVy™ Facet Screw System
Vy Spine, LLC
Orthopedic
169d
Cleared
Jan 16, 2026
Ion-C
SurGenTec, LLC
Orthopedic
227d
Cleared
Dec 04, 2025
FFX Facet Fixation System
Sc Medica
Orthopedic
273d
Cleared
Nov 20, 2025
CORUS-LX Implant
Providence Medical Technology, Inc.
Orthopedic
55d
Cleared
Oct 16, 2025
FFX Facet Fixation System
Sc Medica
Orthopedic
99d
Cleared
Jul 10, 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
Providence Medical Technology, Inc.
Orthopedic
20d
Cleared
May 22, 2025
Arthrex Spine Compression FT Screw
Arthrex, Inc.
Orthopedic
56d
Cleared
May 21, 2025
The Karma® Fixation System
Spinal Elements, Inc.
Orthopedic
268d
Cleared
Mar 24, 2025
AERO MIS Facet Fusion System
Aurora Spine
Orthopedic
97d
Cleared
Dec 04, 2024
Ion 3D
SurGenTec, LLC
Orthopedic
50d
Cleared
Sep 20, 2024
zLOCK Lumbar Facet Fixation System
Zygofix , Ltd.
Orthopedic
16d
Cleared
Jun 25, 2024
PMT Posterior Cervical Stabilization System (PCSS)
Providence Medical Technology, Inc.
Orthopedic
70d
Cleared
Jun 17, 2024
Ion 3D
SurGenTec, LLC
Orthopedic
31d
Cleared
May 09, 2024
SC Medica FFX
Sc Medica
Orthopedic
268d
Cleared
Apr 18, 2024
zLOCK Lumbar Facet Fixation System
Zygofix , Ltd.
Orthopedic
98d
Cleared
Feb 08, 2024
Ion 3D
SurGenTec, LLC
Orthopedic
28d
Cleared
Dec 19, 2023
PMT Facet Fixation System, Lumbar (PMT FFS-LX)
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
K&J Consulting Corporation
Orthopedic
89d
Cleared
Aug 11, 2023
PMT Expandable Cage (PMT EXP)
Providence Medical Technology, Inc.
Orthopedic
190d
Cleared
Dec 09, 2022
PMT Facet Fixation System (PMT FFS)
Providence Medical Technology, Inc.
Orthopedic
252d
Cleared
Oct 05, 2022
FaSet Fixation System
Dio Medical Corporation
Orthopedic
47d
Cleared
Feb 25, 2022
Ion Facet Screw System
SurGenTec, LLC
Orthopedic
254d
Cleared
Dec 16, 2019
CORRIDOR Fixation System
Globus Medical, Inc.
Orthopedic
77d
About Product Code MRW - Regulatory Context
510(k) Submission Activity
78 total 510(k) submissions under product code MRW since 1997, with 78 receiving FDA clearance (average review time: 120 days).
Submission volume has increased in recent years - 13 submissions in the last 24 months compared to 10 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - MRW Product Code
FDA review times for MRW submissions have been consistent, averaging 120 days recently vs 120 days historically.
MRW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →