Cleared Traditional

K132852 - PEEK CAGE FOR THE VERTEBRAL SPINE

K132852 is an FDA 510(k) clearance for PEEK CAGE FOR THE VERTEBRAL SPINE, manufactured by Neoortho Produtos Ortopedicos S/A. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K132852 · Neoortho Produtos Ortopedicos S/A · Orthopedic device
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May 2014
Decision
260d
Days
Class 2
Risk

K132852 is an FDA 510(k) clearance for the PEEK CAGE FOR THE VERTEBRAL SPINE. 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 Neoortho Produtos Ortopedicos S/A (Aventura, US). The FDA issued a Cleared decision on May 29, 2014 after a review of 260 days - an extended review 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: 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 Neoortho Produtos Ortopedicos S/A devices

FDA 510(k) Submission Details - K132852

510(k) Number K132852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2013
Decision Date May 29, 2014
Days to Decision 260 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
138d slower than avg
Panel avg: 122d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

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 659
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K132852.
COROENT THORACOLUMBAR IMPLANTS
K140659 · Nu Vasive, Incorporated · Jun 2014
BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL
K140759 · Medos International SARL · Jun 2014
BN LUMBAR CAGE SYSTEM
K140564 · Medyssey USA, Inc. · Jun 2014
SKYHAWK INTERBODY FUSION SYSTEM
K140709 · Orthofix, Inc. · May 2014
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
K133418 · Seaspine, Inc. · May 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · Exactech, Inc. · Apr 2014