Cleared Special

NOVA Minimally Invasive System (K242899) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K242899 · Baui Biotech Co., Ltd. · Orthopedic device
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Oct 2024
Decision
24d
Days
Class 2
Risk

K242899 is an FDA 510(k) clearance for the NOVA Minimally Invasive 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 October 17, 2024 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baui Biotech Co., Ltd. devices

Submission Details

510(k) Number K242899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2024
Decision Date October 17, 2024
Days to Decision 24 days
Submission Type Special
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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K242899.
CarboClear® Hybrid Pedicle Screw System
K243106 · CarboFix Orthopedics , Ltd. · Nov 2024
Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
K242350 · Spinal Alignment Solutions, Inc. · Oct 2024
CD Horizon™ Spinal System
K243007 · Medtronic Sofamor Danek USA, Inc. · Oct 2024
GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
K230325 · Greens Surgicals Pvt. , Ltd. · Oct 2024
MSFX MIKRON SPINAL FIXATION SYSTEM
K241657 · Mikron Makina Sanayi VE Ticaret Ltd. Sti. · Sep 2024
Pitkar Spinal Pedicle Screw System
K240233 · S.H.Pitkar Orthotools Pvt. , Ltd. · Sep 2024