Cleared Traditional

K131350 - CALIX LUMBAR SPINAL IMPLANT SYSTEM

K131350 is an FDA 510(k) clearance for CALIX LUMBAR SPINAL IMPLANT SYSTEM, manufactured by X-Spine Systems, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K131350 · X-Spine Systems, Inc. · Orthopedic device
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Oct 2013
Decision
166d
Days
Class 2
Risk

K131350 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 October 23, 2013 after a review of 166 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

FDA 510(k) Submission Details - K131350

510(k) Number K131350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2013
Decision Date October 23, 2013
Days to Decision 166 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
44d slower than avg
Panel avg: 122d · This submission: 166d
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 853
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K131350.
CRESCENT SPINAL SYSTEM
K133216 · Medtronic Sofamor Danek, Inc. · Nov 2013
PERIMETER INTERBODY FUSION DEVICE
K131669 · Medtronic Sofamor Danek USA, Inc. · Nov 2013
BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM
K130274 · Elite Surgical Supplies (Pty), Ltd. · Oct 2013
PROW FUSION
K130254 · Nlt Spine, Ltd. · Oct 2013
IDYS LIF CAGES
K131178 · Clariance · Oct 2013
CEZANNE II INTERBODY FUSION SYSTEM
K131981 · Accel Spine · Oct 2013