Cleared Traditional

K180071 - STYLO Interbody Fusion Device

K180071 is the FDA 510(k) clearance for STYLO Interbody Fusion Device by Legend Spine Technologies. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K180071 · Legend Spine Technologies · Orthopedic device
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May 2018
Decision
114d
Days
Class 2
Risk

K180071 is an FDA 510(k) clearance for the STYLO Interbody Fusion Device. 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 Legend Spine Technologies (Bethlehem, US). The FDA issued a Cleared decision on May 3, 2018 after a review of 114 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 Legend Spine Technologies devices

Submission Details

510(k) Number K180071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2018
Decision Date May 03, 2018
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
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 Consultant

Mrc/X, LLC
Christine Scifert

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 595
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K180071.
NuVasive® XLX Interbody System
K173892 · Nu Vasive, Incorporated · May 2018
Hexanium® TLIF
K180437 · Spinevision, S.A.S. · May 2018
EVOL Spinal Interbody System, EVOS Lumbar Interbody System
K180891 · Cutting Edge Spine, LLC · May 2018
ACRON™ TLIF System
K171151 · Spinemed Ges.M.B.H · Apr 2018
UNiD Patient Specific 3D printed cage
K173782 · Medicrea International SA · Apr 2018
HALF DOME Posterior Lumbar Interbody System
K172947 · Astura Medical · Apr 2018