Cleared Traditional

K182470 - Plateau Spacer System

K182470 is the FDA 510(k) clearance for Plateau Spacer System by Life Spine. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K182470 · Life Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
77d
Days
Class 2
Risk

K182470 is an FDA 510(k) clearance for the Plateau Spacer System. 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 Life Spine (Huntley, US). The FDA issued a Cleared decision on November 26, 2018 after a review of 77 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 Life Spine devices

Submission Details

510(k) Number K182470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2018
Decision Date November 26, 2018
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 595
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K182470.
PATRIOT® Lumbar Spacers, SUSTAIN® Spacers
K181357 · Globus Medical, Inc. · Dec 2018
MectaLIF Posterior Extension
K181970 · Medacta International S.A. · Dec 2018
ATEC ALIF and LLIF Spacer System
K182746 · Alphatec Spine, Inc. · Nov 2018
Velofix TLIF Cage
K181829 · U&I Corporation · Nov 2018
ostaPek Interbody Fusion Cages
K181963 · Coligne AG · Nov 2018
Spinal Elements Ti-Bond coated devices
K181837 · Spinal Elements, Inc. · Nov 2018