Cleared Traditional

K131077 - LIFE SPINE PLATEAU SPACER SYSTEM

K131077 is the FDA 510(k) clearance for LIFE SPINE 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 91-day FDA review.

K131077 · Life Spine · Orthopedic device
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Jul 2013
Decision
91d
Days
Class 2
Risk

K131077 is an FDA 510(k) clearance for the LIFE SPINE 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 (Hoffman Estates, US). The FDA issued a Cleared decision on July 17, 2013 after a review of 91 days - within the typical 510(k) review window.

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: 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.

View all Life Spine devices

Submission Details

510(k) Number K131077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2013
Decision Date July 17, 2013
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 K131077.
EXPANDABLE LUMBAR INTERBODY SYSTEM
K130820 · Nu Vasive, Incorporated · Aug 2013
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
K130478 · Globus Medical, Inc. · Jul 2013
CAPSTONE(R) SPINAL SYSTEM
K123027 · Medtronic Sofamor Danek, Inc. · Jul 2013
MECTALIF
K131671 · Medacta International · Jul 2013
PLATEAU SPACER SYSTEM TITANIUM
K130630 · Life Spine, Inc. · Jun 2013
ALEUTIAN SPINAL SYSTEM
K130699 · K2m, Inc. · May 2013