Cleared Special

K132589 - ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)

K132589 is an FDA 510(k) clearance for ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO), manufactured by Life Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 50-day FDA review.

K132589 · Life Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
50d
Days
Class 2
Risk

K132589 is an FDA 510(k) clearance for the ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO). Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Life Spine, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on October 8, 2013 after a review of 50 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K132589

510(k) Number K132589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2013
Decision Date October 08, 2013
Days to Decision 50 days
Submission Type Special
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
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 667
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K132589.
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SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST
K132324 · Medos International SARL · Sep 2013
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
K132366 · Accel Spine · Sep 2013
NUVASIVE DECADE LATERAL PLATE SYSTEM
K130868 · Nuvasive, Inc. · Aug 2013
K132589 · ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)
Download PDF FDA Summary Life Spine, Inc.