Cleared Traditional

STERISPINE LC CAGE (K151756) - FDA 510(k) Clearance

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

K151756 · Safe Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
53d
Days
Class 2
Risk

K151756 is an FDA 510(k) clearance for the STERISPINE LC CAGE. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Safe Orthopaedics (Eragny Sur Oise, FR). The FDA issued a Cleared decision on August 21, 2015 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Safe Orthopaedics devices

Submission Details

510(k) Number K151756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2015
Decision Date August 21, 2015
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 890
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K151756.
Exceed® Biplanar Expandable Interbody System
K261159 · Spine Wave, Inc. · May 2026
BMD Titanium Spinal Fusion System
K253894 · Global Biomedica s.r.o. · May 2026
Ventana® P/T Lumbar Interbody System
K260506 · Spinal Elements, Inc. · May 2026
VersaLift Expandable System
K260837 · Life Spine, Inc. · May 2026
aprevo® anterior and lateral lumbar interbody system
K260385 · Carlsmed, Inc. · May 2026
BEE PLIF Cage
K261067 · NGMedical GmbH · Apr 2026