Cleared Traditional

K161766 - PathLoc-L MIS Spinal System

K161766 is the FDA 510(k) clearance for PathLoc-L MIS Spinal System by L & K Biomed Co., Ltd.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K161766 · L & K Biomed Co., Ltd. · Orthopedic device
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Aug 2016
Decision
56d
Days
Class 2
Risk

K161766 is an FDA 510(k) clearance for the PathLoc-L MIS 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 L & K Biomed Co., Ltd. (Giheung-Gu, Yongin-Si, KR). The FDA issued a Cleared decision on August 22, 2016 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all L & K Biomed Co., Ltd. devices

Submission Details

510(k) Number K161766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2016
Decision Date August 22, 2016
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 Peers - NKB Thoracolumbosacral Pedicle Screw System

All 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K161766.
CD HORIZON® Spinal System
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Genesys Spine TiLock Cortical Spinal System
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Threshold™ Pedicular Fixation System
K161694 · Spineology, Inc. · Jul 2016
Expedium Spine System, VIPER and VIPER 2 Systems
K160904 · Medos International SARL · Jul 2016