Cleared Traditional

K262572 - Symmetrix™ PX Spinal System

K262572 is an FDA 510(k) clearance for Symmetrix PX Spinal System, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K262572 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
94d
Days
Class 2
Risk

K262572 is an FDA 510(k) clearance for the Symmetrix™ PX Spinal 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 Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on October 29, 2026 after a review of 94 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.

FDA 510(k) Submission Details - K262572

510(k) Number K262572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2026
Decision Date October 29, 2026
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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 K262572.
Calibrate MAX System
K262646 · Alphatec Spine, 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
K262572 · Symmetrix™ PX Spinal System
Download PDF FDA Summary Medtronic Sofamor Dan…