Cleared Traditional

K130274 - BIOLIGN ACIF SYSTEMS

K130274 is the FDA 510(k) clearance for BIOLIGN ACIF SYSTEMS by Elite Surgical Supplies (Pty), Ltd.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K130274 · Elite Surgical Supplies (Pty), Ltd. · Orthopedic device
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Oct 2013
Decision
267d
Days
Class 2
Risk

K130274 is an FDA 510(k) clearance for the BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF 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 Elite Surgical Supplies (Pty), Ltd. (Pretoria West Industrial, ZA). The FDA issued a Cleared decision on October 29, 2013 after a review of 267 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 Elite Surgical Supplies (Pty), Ltd. devices

Submission Details

510(k) Number K130274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2013
Decision Date October 29, 2013
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
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 596
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K130274.
CLYDESDALE SPINAL SYSTEM
K132897 · Medtronic Sofamor Danek, Inc. · Dec 2013
CRESCENT SPINAL SYSTEM
K133216 · Medtronic Sofamor Danek, Inc. · Nov 2013
PERIMETER INTERBODY FUSION DEVICE
K131669 · Medtronic Sofamor Danek USA, Inc. · Nov 2013
STAXX IBL SYSTEM
K132719 · Spine Wave, Inc. · Oct 2013
PERIMETER INTERBODY FUSION DEVICE
K132700 · Medtronic Sofamor Danek, Inc. · Sep 2013
RAMPART-O, RAMPART-T
K132053 · Spineology, Inc. · Sep 2013