Cleared Traditional

K262574 - Convoy Expandable Corpectomy System

K262574 is an FDA 510(k) clearance for Convoy Expandable Corpectomy System, manufactured by SeaSpine Orthopedics Corporation. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K262574 · SeaSpine Orthopedics Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
94d
Days
Class 2
Risk

K262574 is an FDA 510(k) clearance for the Convoy Expandable Corpectomy System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on October 29, 2026 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K262574

510(k) Number K262574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2026
Decision Date October 29, 2026
Days to Decision 94 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MQP Spinal Vertebral Body Replacement Device

All 279
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K262574.
Vertiwedge® Intraosseous System
K261810 · Foundation Surgical Group · Jul 2026
POSEIDON ST
K261031 · Signus Medinzintechnik GmbH · Jul 2026
VyBrate™ VBR System
K253158 · Vy Spine, LLC · Jan 2026
Vertiwedge® Intraosseous System
K241468 · Foundation Surgical Group, Inc. · Nov 2024
KONG®-TL VBR System and KONG® C VBR System
K232790 · Icotec AG · Apr 2024
DOMINION Expandable Corpectomy System
K233359 · Astura Medical · Mar 2024
K262574 · Convoy Expandable Corpectomy System
Download PDF FDA Summary SeaSpine Orthopedics …