Cleared Traditional

K100404 - ASCENDX VCF REDUCTION SYSTEM

K100404 is an FDA 510(k) clearance for ASCENDX VCF REDUCTION SYSTEM, manufactured by Aoi Medical, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 1032-day FDA review.

K100404 · Aoi Medical, Inc. · Orthopedic device
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Dec 2012
Decision
1032d
Days
Class 2
Risk

K100404 is an FDA 510(k) clearance for the ASCENDX VCF REDUCTION SYSTEM. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Aoi Medical, Inc. (Philedelphia, US). The FDA issued a Cleared decision on December 14, 2012 after a review of 1032 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Aoi Medical, Inc. devices

FDA 510(k) Submission Details - K100404

510(k) Number K100404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date December 14, 2012
Days to Decision 1032 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
910d slower than avg
Panel avg: 122d · This submission: 1032d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDN Device Classification - Class 2, Special Controls

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 53
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