Cleared Traditional

K161710 - SAGICO IBF SYSTEM – ARIA LUMBAR

K161710 is an FDA 510(k) clearance for SAGICO IBF SYSTEM – ARIA LUMBAR, manufactured by Spinal Analytics & Geometrical Impant Co, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K161710 · Spinal Analytics & Geometrical Impant Co, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
373d
Days
Class 2
Risk

K161710 is an FDA 510(k) clearance for the SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL. 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 Spinal Analytics & Geometrical Impant Co, LLC (Tampa, US). The FDA issued a Cleared decision on June 29, 2017 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Spinal Analytics & Geometrical Impant Co, LLC devices

FDA 510(k) Submission Details - K161710

510(k) Number K161710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2016
Decision Date June 29, 2017
Days to Decision 373 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
251d slower than avg
Panel avg: 122d · This submission: 373d
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 K161710.
CONCORDE LIFT
K171425 · Medos International SARL · Jul 2017
Genesys Spine Apache Interbody Fusion System
K171656 · Genesys Spine · Jul 2017
CRESCENT™ Spinal System
K171031 · Medtronic Sofamor Danek · Jul 2017
NuVasive® CoRoent® Thoracolumbar System
K170962 · Nu Vasive, Incorporated · Jun 2017
FUSE Spinal System
K171468 · Medtronic Sofamor Danek · Jun 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212 · Medtronic Sofamor Danek USA, Inc. · May 2017