MQP · Class II · 21 CFR 888.3060

FDA Product Code MQP: Spinal Vertebral Body Replacement Device

FDA product code MQP covers spinal vertebral body replacement devices used to reconstruct the anterior column of the spine.

These expandable or fixed-height titanium or PEEK cages are used to replace one or more vertebral bodies removed due to tumor, infection, trauma, or deformity, restoring anterior column support and spinal alignment while facilitating fusion.

MQP devices are Class II medical devices, regulated under 21 CFR 888.3060 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Medtronic Sofamor Danek, Globus Medical, Inc. and Interpore Cross Intl..

279
Total
279
Cleared
114d
Avg days
1999
Since
Stable submission activity - 4 submissions in the last 2 years
Consistent review times: 108d avg (recent)

FDA 510(k) Cleared Spinal Vertebral Body Replacement Device Devices (Product Code MQP)

279 devices
1–24 of 279
Cleared Jan 07, 2026
VyBrate™ VBR System
K253158
Vy Spine, LLC
Orthopedic · 103d
Cleared Nov 07, 2024
Vertiwedge® Intraosseous System
K241468
Foundation Surgical Group, Inc.
Orthopedic · 167d
Cleared Apr 04, 2024
KONG®-TL VBR System and KONG® C VBR System
K232790
Icotec AG
Orthopedic · 206d
Cleared Mar 08, 2024
DOMINION Expandable Corpectomy System
K233359
Astura Medical
Orthopedic · 161d
Cleared Feb 13, 2024
VerteLoc Spinal System
K231134
Signature Orthopaedics Pty, Ltd.
Orthopedic · 298d
Cleared Oct 06, 2023
Ascend VBR System, Ascend NanoTec VBR System
K232173
Alphatec Spine, Inc.
Orthopedic · 77d
Cleared Oct 06, 2022
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
K211892
Arftx Medical, LLC
Orthopedic · 472d
Cleared Dec 23, 2020
F3D Corpectomy System
K202637
Corelink, LLC
Orthopedic · 103d
Cleared May 29, 2020
KONG-TL VBR System, KONG-C VBR System
K200235
Icotec AG
Orthopedic · 120d
Cleared Feb 26, 2020
NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System
K193506
Nu Vasive, Incorporated
Orthopedic · 70d
Cleared Nov 01, 2019
Small VBR™
K192117
Ulrich GmbH & Co. KG
Orthopedic · 87d
Cleared Oct 24, 2019
MediExpand TL Expandable VBR System
K190349
Cmf Medicon Surgical, Inc.
Orthopedic · 252d
Cleared Oct 11, 2019
CarboClear VBR System
K192214
CarboFix Orthopedics , Ltd.
Orthopedic · 57d
Cleared May 23, 2019
SYNMESH System
K183054
Depuy Synthes Spine
Orthopedic · 202d
Cleared May 08, 2019
COLOSSEUM Mesh
K190147
Globus Medical, Inc.
Orthopedic · 99d
Cleared Apr 04, 2019
PYRAMESH™ Implant System
K183197
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 136d
Cleared Feb 22, 2019
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
K183588
Choicespine
Orthopedic · 63d
Cleared Jan 16, 2019
T2 STRATOSPHERE Expandable Corpectomy System
K183510
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Nov 28, 2018
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
K180665
K2m, LLC
Orthopedic · 259d
Cleared Nov 16, 2018
Solidity Vertebral Body Replacement
K181921
Ulrich Medical USA
Orthopedic · 121d
Cleared Sep 19, 2018
FORTIFY Corpectomy Spacers
K173982
Globus Medical, Inc.
Orthopedic · 264d
Cleared Sep 19, 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
K181328
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 124d
Cleared Jun 11, 2018
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System
K173787
Medos International SARL
General & Plastic Surgery · 179d
Cleared Feb 02, 2018
Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage
K173800
Camber Spine Technologies
Orthopedic · 50d

About Product Code MQP - Regulatory Context

510(k) Submission Activity

279 total 510(k) submissions under product code MQP since 1999, with 279 receiving FDA clearance (average review time: 114 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - MQP Product Code

FDA review times for MQP submissions have been consistent, averaging 108 days recently vs 114 days historically.

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