Cleared Traditional

K161231 - Facilis Spinal System

K161231 is an FDA 510(k) clearance for Facilis Spinal System, manufactured by Baui Biotech Co., Ltd.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K161231 · Baui Biotech Co., Ltd. · Orthopedic device
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Jan 2017
Decision
266d
Days
Class 2
Risk

K161231 is an FDA 510(k) clearance for the Facilis™ 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 Baui Biotech Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on January 23, 2017 after a review of 266 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 Baui Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K161231

510(k) Number K161231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2016
Decision Date January 23, 2017
Days to Decision 266 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

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 716
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K161231.
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ENNOVATE Spinal System
K162134 · Aesculap Implant Systems, LLC · Dec 2016
VIPER PRIME™ additions to the VIPER® System
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