Cleared Special

Altus Spine Titanium Interbody Fusion System (K171329) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K171329 · Altus Partners, LLC · Orthopedic device
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Aug 2017
Decision
116d
Days
Class 2
Risk

K171329 is an FDA 510(k) clearance for the Altus Spine Titanium 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 August 29, 2017 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Altus Partners, LLC devices

Submission Details

510(k) Number K171329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2017
Decision Date August 29, 2017
Days to Decision 116 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Modification to existing cleared device.

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 465
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K171329.
NuVasive TLX Interbody System
K171633 · Nu Vasive, Incorporated · Sep 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K171107 · Medtronic Sofamor Danek USA, Inc. · Sep 2017
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
K172199 · Medtronic Sofamor Danek · Sep 2017
The TiBow Expandable Spacer System
K170919 · Life Spine, Inc. · Aug 2017
CONCORDE LIFT
K171425 · Medos International SARL · Jul 2017
CRESCENT™ Spinal System
K171031 · Medtronic Sofamor Danek · Jul 2017