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..
280
Total
280
Cleared
114d
Avg days
1999
Since
Stable submission activity - 4 submissions in the last 2 years
Review times improving: avg
90d
recently vs 114d historically
FDA 510(k) Cleared Spinal Vertebral Body Replacement Device Devices (Product Code MQP)
280 devices
Cleared
Oct 29, 2026
Convoy Expandable Corpectomy System
SeaSpine Orthopedics Corporation
Orthopedic
94d
Cleared
Jul 31, 2026
Vertiwedge® Intraosseous System
Foundation Surgical Group
Orthopedic
60d
Cleared
Jul 10, 2026
POSEIDON ST
Signus Medinzintechnik GmbH
Orthopedic
102d
Cleared
Jan 07, 2026
VyBrate™ VBR System
Vy Spine, LLC
Orthopedic
103d
Cleared
Nov 07, 2024
Vertiwedge® Intraosseous System
Foundation Surgical Group, Inc.
Orthopedic
167d
Cleared
Apr 04, 2024
KONG®-TL VBR System and KONG® C VBR System
Icotec AG
Orthopedic
206d
Cleared
Mar 08, 2024
DOMINION Expandable Corpectomy System
Astura Medical
Orthopedic
161d
Cleared
Feb 13, 2024
VerteLoc Spinal System
Signature Orthopaedics Pty, Ltd.
Orthopedic
298d
Cleared
Oct 06, 2023
Ascend VBR System, Ascend NanoTec VBR System
Alphatec Spine, Inc.
Orthopedic
77d
Cleared
Oct 06, 2022
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
Arftx Medical, LLC
Orthopedic
472d
Cleared
Dec 23, 2020
F3D Corpectomy System
Corelink, LLC
Orthopedic
103d
Cleared
May 29, 2020
KONG-TL VBR System, KONG-C VBR System
Icotec AG
Orthopedic
120d
Cleared
Feb 26, 2020
NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System
Nu Vasive, Incorporated
Orthopedic
70d
Cleared
Nov 01, 2019
Small VBR™
Ulrich GmbH & Co. KG
Orthopedic
87d
Cleared
Oct 24, 2019
MediExpand TL Expandable VBR System
Cmf Medicon Surgical, Inc.
Orthopedic
252d
Cleared
Oct 11, 2019
CarboClear VBR System
CarboFix Orthopedics , Ltd.
Orthopedic
57d
Cleared
May 23, 2019
SYNMESH System
Depuy Synthes Spine
Orthopedic
202d
Cleared
May 08, 2019
COLOSSEUM Mesh
Globus Medical, Inc.
Orthopedic
99d
Cleared
Apr 04, 2019
PYRAMESH™ Implant System
Medtronic Sofamor Danek USA, Inc.
Orthopedic
136d
Cleared
Feb 22, 2019
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
Choicespine
Orthopedic
63d
Cleared
Jan 16, 2019
T2 STRATOSPHERE Expandable Corpectomy System
Medtronic Sofamor Danek USA, Inc.
Orthopedic
29d
Cleared
Nov 28, 2018
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
K2m, LLC
Orthopedic
259d
Cleared
Nov 16, 2018
Solidity Vertebral Body Replacement
Ulrich Medical USA
Orthopedic
121d
Cleared
Sep 19, 2018
FORTIFY Corpectomy Spacers
Globus Medical, Inc.
Orthopedic
264d
About Product Code MQP - Regulatory Context
510(k) Submission Activity
280 total 510(k) submissions under product code MQP since 1999, with 280 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
Recent submissions under MQP have taken an average of 90 days to reach a decision - down from 114 days historically, suggesting improved FDA processing for this classification.
MQP devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →