Cleared Traditional

K170119 - Calix Lumbar Spinal Implant System

K170119 is the FDA 510(k) clearance for Calix Lumbar Spinal Implant System by X-Spine Systems, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K170119 · X-Spine Systems, Inc. · Orthopedic device
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Sep 2017
Decision
259d
Days
Class 2
Risk

K170119 is an FDA 510(k) clearance for the Calix Lumbar Spinal Implant 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 X-Spine Systems, Inc. (Miamisburg, US). The FDA issued a Cleared decision on September 29, 2017 after a review of 259 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 X-Spine Systems, Inc. devices

Submission Details

510(k) Number K170119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2017
Decision Date September 29, 2017
Days to Decision 259 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 122d · This submission: 259d
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 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K170119.
SeaSpine Ventura NanoMetalene System
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NuVasive® Modulus XLIF Interbody System
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ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
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NuVasive TLX Interbody System
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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