Cleared Abbreviated

BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 (K123225) - FDA 510(k) Clearance

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

K123225 · Aap Biomaterials GmbH & Co. KG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
151d
Days
Class 2
Risk

K123225 is an FDA 510(k) clearance for the BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Aap Biomaterials GmbH & Co. KG (Dieburg, DE). The FDA issued a Cleared decision on March 15, 2013 after a review of 151 days - an extended review 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 & Co. KG devices

Submission Details

510(k) Number K123225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2012
Decision Date March 15, 2013
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LOD Bone Cement
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 - LOD Bone Cement

All 47
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K123225.
OrthoSteady G Bone Cement
K173494 · G21, S.R.L. · Mar 2018
Biomet Bone Cement R
K172408 · Biomet, Inc. · Oct 2017
Refobacin Bone Cement R
K171540 · Biomet, Inc. · Aug 2017
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
K092150 · Biomet, Inc. · Oct 2009
SMARTSET MV BONE CEMENT
K081155 · DePuy Orthopaedics, Inc. · May 2008
SIMPLEX P SPEEDSET BONE CEMENT
K053198 · Howmedica Osteonics Corp. · Jan 2006