Cleared Traditional

K223301 - ASTRA & AVANT Navigation Instruments Sy...

K223301 is an FDA 510(k) clearance for ASTRA & AVANT Navigation Instruments Sy..., manufactured by Spinecraft, LLC. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K223301 · Spinecraft, LLC · Orthopedic device
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Jul 2023
Decision
266d
Days
Class 2
Risk

K223301 is an FDA 510(k) clearance for the ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instrume.... Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Spinecraft, LLC (Westmont, US). The FDA issued a Cleared decision on July 20, 2023 after a review of 266 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 Spinecraft, LLC devices

FDA 510(k) Submission Details - K223301

510(k) Number K223301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2022
Decision Date July 20, 2023
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLO Device Classification - Class 2, Special Controls

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 370
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K223301.
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