Cleared Traditional

K160663 - Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)

K160663 is an FDA 510(k) clearance for Lumbar Interbody Fusion System (ALIF, manufactured by Evolution Spine, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K160663 · Evolution Spine, LLC · Orthopedic device
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Nov 2016
Decision
252d
Days
Class 2
Risk

K160663 is an FDA 510(k) clearance for the Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF). 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 Evolution Spine, LLC (Dallas, US). The FDA issued a Cleared decision on November 16, 2016 after a review of 252 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 Evolution Spine, LLC devices

FDA 510(k) Submission Details - K160663

510(k) Number K160663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2016
Decision Date November 16, 2016
Days to Decision 252 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
130d slower than avg
Panel avg: 122d · This submission: 252d
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 Consultant

Leonine, LLC
JOHN SIEGEL

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 849
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K160663.
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)
K162103 · Choicespine, LP · Nov 2016
Xsert Lumbar Expandable Interbody System
K160959 · X-Spine Systems, Inc. · Nov 2016
Luna 3D Interbody Fusion System
K162431 · Benvenue Medical, Inc. · Nov 2016
Tritanium® PL Cage
K162262 · Stryker · Nov 2016
Amendia Interbody Fusion Devices
K160924 · Amendia, Inc. · Nov 2016
Genesys Spine Apache® Anterior Lumbar Interbody Fusion System
K161438 · Genesys Spine · Nov 2016