Cleared Traditional

K252542 - LEO Spinal System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252542 · ZheJiang Decans Medical Devices Co., Ltd. · Orthopedic device
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Apr 2026
Decision
260d
Days
Class 2
Risk

K252542 is an FDA 510(k) clearance for the LEO Spinal System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by ZheJiang Decans Medical Devices Co., Ltd. (Jiaxing City, CN). The FDA issued a Cleared decision on April 29, 2026 after a review of 260 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 ZheJiang Decans Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K252542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2025
Decision Date April 29, 2026
Days to Decision 260 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
138d slower than avg
Panel avg: 122d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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

Sinow Medical AS
Xiaoqing Xue

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 - NKB Thoracolumbosacral Pedicle Screw System

All 895
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K252542.
PERLA® TL Posterior Thoraco-lumbar Fixation System
K253966 · Spineart SA · May 2026
M.U.S.T. Pedicle Screw System - Extension
K253940 · Medacta International S.A. · Apr 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
K260216 · Medtronic Sofamor Danek USA, Inc. · Apr 2026
ARx® SAI Implant System
K254274 · Life Spine, Inc. · Apr 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K260786 · S.M.A.I.O · Apr 2026
OSTEOMNI SPINAL FIXATION SYSTEM
K254247 · OSTEOMNI, Inc. · Feb 2026