Cleared Traditional

K080860 - CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080860 · Creaspine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
63d
Days
Class 2
Risk

K080860 is an FDA 510(k) clearance for the CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Creaspine (North Attleboro, US). The FDA issued a Cleared decision on May 29, 2008 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Creaspine devices

Submission Details

510(k) Number K080860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2008
Decision Date May 29, 2008
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 276
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K080860.
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
VerteLoc Spinal System
K231134 · Signature Orthopaedics Pty, Ltd. · Feb 2024
Ascend VBR System, Ascend NanoTec VBR System
K232173 · Alphatec Spine, Inc. · Oct 2023