Cleared Traditional

Mg OSTEOINJECT™ (K234013) - FDA 510(k) Clearance

Also marketed or referenced as:
Mg OSTEOREVIVE™ Mg OSTEOCRETE™

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

K234013 · Bone Solutions, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
48d
Days
Class 2
Risk

K234013 is an FDA 510(k) clearance for the Mg OSTEOINJECT™. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Bone Solutions, Inc. (Colleyville, US). The FDA issued a Cleared decision on February 5, 2024 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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 Bone Solutions, Inc. devices

Submission Details

510(k) Number K234013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2023
Decision Date February 05, 2024
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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

PaxMed International, LLC
Kevin Thomas

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 - MQV Filler, Bone Void, Calcium Compound

All 201
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K234013.
NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)
K240404 · Novabone Products, LLC · Mar 2024
Cerament Bone Void Filler
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ReBOSSIS
K240453 · Orthorebirth Co., Ltd. · Mar 2024
MagnetOs Granules
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MagnetOs Putty
K230736 · Kuros Biosciences B.V · Dec 2023
Tactoset® Injectable Bone Substitute
K231968 · Anika Therapeutics, Inc. · Dec 2023