Cleared Abbreviated

K090460 - BONOS INJECT

K090460 is an FDA 510(k) clearance for BONOS INJECT, manufactured by Aap Biomaterials GmbH. The device is a Class 2 Orthopedic device with product code NDN cleared through the Abbreviated 510(k) pathway after a 50-day FDA review.

K090460 · Aap Biomaterials GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
50d
Days
Class 2
Risk

K090460 is an FDA 510(k) clearance for the BONOS INJECT. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Aap Biomaterials GmbH (Dieburg, DE). The FDA issued a Cleared decision on April 14, 2009 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Aap Biomaterials GmbH devices

FDA 510(k) Submission Details - K090460

510(k) Number K090460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2009
Decision Date April 14, 2009
Days to Decision 50 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Standards-based clearance path.

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
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K090460.
VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
K091606 · Stryker Corp. · Oct 2009
INFLATABLE BONE TAMP
K090211 · Cardinal Health, Inc. · Jul 2009
CORTOSS BONE AUGMENTATION MATERIAL
K080108 · Orthovita, Inc. · Jun 2009
STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
K072118 · Stryker Corp. · Dec 2007
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
K072133 · Cardinal Health, Inc. · Nov 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K070527 · Medtronic Sofamor Danek · May 2007