Cleared Traditional

BonOs Inject Bone Cement (K212489) - FDA 510(k) Clearance

Also marketed or referenced as:
NEO Pedicle Screw System

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212489 · Neo Medical SA · Orthopedic device
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Oct 2021
Decision
80d
Days
Class 2
Risk

K212489 is an FDA 510(k) clearance for the BonOs Inject Bone Cement. Classified as Bone Cement, Posterior Screw Augmentation (product code PML), Class II - Special Controls.

Submitted by Neo Medical SA (Villette (Lavaux), CH). The FDA issued a Cleared decision on October 28, 2021 after a review of 80 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neo Medical SA devices

Submission Details

510(k) Number K212489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2021
Decision Date October 28, 2021
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PML Bone Cement, Posterior Screw Augmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
Definition The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.
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 Consultant

Meditec Consulting GmbH
Sandra Soniec

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PML Bone Cement, Posterior Screw Augmentation

All 14
Devices cleared under the same product code (PML) and FDA review panel - the closest regulatory comparables to K212489.
VADER® Pedicle System, G21 Cement
K222789 · Icotec AG · Jan 2023
Invictus® Bone Cement, Invictus Spinal Fixation System
K221926 · Alphatec Spine, Inc. · Dec 2022
BonOs® Inject Bone Cement
K222256 · Neo Medical SA · Aug 2022
G21 Cement, VADER® Pedicle System
K200596 · Icotec AG · Oct 2020
CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement
K201362 · Medtronic · Aug 2020
Vertaplex HV High Viscosity Radiopaque Bone Cement
K192818 · Stryker Corporation · Mar 2020