Cleared Traditional

K253011 - Catalyft PL Expandable Interbody System

K253011 is the FDA 510(k) clearance for Catalyft PL Expandable Interbody System by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K253011 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Jul 2026
Decision
301d
Days
Class 2
Risk

K253011 is an FDA 510(k) clearance for the Catalyft PL Expandable 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 Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on July 17, 2026 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K253011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2025
Decision Date July 17, 2026
Days to Decision 301 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
179d slower than avg
Panel avg: 122d · This submission: 301d
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 595
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K253011.
TruLift Expandable System
K261430 · Life Spine, Inc. · Jul 2026
Symmetrix™ L Spinal System
K261020 · Medtronic Sofamor Danek USA, Inc. · Jul 2026
Admiral ACP System
K253420 · SeaSpine Orthopedics Corporation · Jul 2026
Exceed® Biplanar Expandable Interbody System
K261159 · Spine Wave, Inc. · May 2026
BMD Titanium Spinal Fusion System
K253894 · Global Biomedica s.r.o. · May 2026
Ventana® P/T Lumbar Interbody System
K260506 · Spinal Elements, Inc. · May 2026