Cleared Traditional

K170553 - Altus Spine Interbody Fusion System

K170553 is an FDA 510(k) clearance for Altus Spine Interbody Fusion System, manufactured by Altus Partners, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K170553 · Altus Partners, LLC · Orthopedic device
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Dec 2017
Decision
280d
Days
Class 2
Risk

K170553 is an FDA 510(k) clearance for the Altus Spine Interbody Fusion 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 Altus Partners, LLC (West Chester, US). The FDA issued a Cleared decision on December 1, 2017 after a review of 280 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 Altus Partners, LLC devices

FDA 510(k) Submission Details - K170553

510(k) Number K170553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2017
Decision Date December 01, 2017
Days to Decision 280 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
158d slower than avg
Panel avg: 122d · This submission: 280d
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 649
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K170553.
Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System
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K172419 · U&I Corporation · Dec 2017
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Lucent®
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K172020 · Signature Orthopaedics Pty, Ltd. · Nov 2017
IMPIX 3D Print Cages
K163595 · Medicrea International SA · Nov 2017