Cleared Traditional

K222455 - Calibrate LTX Interbody System

K222455 is the FDA 510(k) clearance for Calibrate LTX Interbody System by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K222455 · Alphatec Spine, Inc. · Orthopedic device
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Nov 2022
Decision
95d
Days
Class 2
Risk

K222455 is an FDA 510(k) clearance for the Calibrate LTX Interbody 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 Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 18, 2022 after a review of 95 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. 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 Alphatec Spine, Inc. devices

Submission Details

510(k) Number K222455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2022
Decision Date November 18, 2022
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 K222455.
Hexanium PLIF
K223251 · Spinevision, S.A.S. · Dec 2022
Southern Transforaminal Lumbar Interbody Fusion (TLIF)
K221182 · Southern Medical (Pty) , Ltd. · Dec 2022
TruLift Lateral Expandable Spacer System & Lateral Plate System
K221806 · Life Spine, Inc. · Dec 2022
WaveForm A Interbody System
K222732 · SeaSpine Orthopedics Corporation · Nov 2022
ABTross ALIF Expandable Cage System
K221719 · Aegis Spine, Inc. · Nov 2022
Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
K223065 · Adcura, Inc. · Oct 2022