Cleared Special

BonOs® Inject Bone Cement (K222256) - FDA 510(k) Clearance

Also marketed or referenced as:
NEO Pedicle Screw System™

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

K222256 · Neo Medical SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
30d
Days
Class 2
Risk

K222256 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 August 26, 2022 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Neo Medical SA devices

Submission Details

510(k) Number K222256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2022
Decision Date August 26, 2022
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K222256.
PERLA® TL System
K230774 · Spineart · Jun 2023
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
K212489 · Neo Medical SA · Oct 2021
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