Cleared Traditional

K262646 - Calibrate MAX System

Also marketed or referenced as:
Calibrate NanoTec MAX System Calibrate CCX Interbody System Calibrate NanoTec CCX Interbody System

K262646 is an FDA 510(k) clearance for Calibrate MAX System, manufactured by Alphatec Spine, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K262646 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
83d
Days
Class 2
Risk

K262646 is an FDA 510(k) clearance for the Calibrate MAX 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 October 21, 2026 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262646

510(k) Number K262646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2026
Decision Date October 21, 2026
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 898
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K262646.
Symmetrix™ PX Spinal System
K262572 · Medtronic Sofamor Danek USA, Inc. · Oct 2026
SCALA® TL
K261049 · Spineart SA · Aug 2026
TruLift Expandable System
K261430 · Life Spine, Inc. · Jul 2026
Catalyft PL Expandable Interbody System
K253011 · Medtronic Sofamor Danek USA, Inc. · Jul 2026
Symmetrix™ L Spinal System
K261020 · Medtronic Sofamor Danek USA, Inc. · Jul 2026
Admiral ACP System
K253420 · SeaSpine Orthopedics Corporation · Jul 2026
K262646 · Calibrate MAX System
Download PDF FDA Summary Alphatec Spine, Inc.