Cleared Traditional

Synthetic Bone Putty (K240458) - FDA 510(k) Clearance

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

K240458 · Ventris Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
20d
Days
Class 2
Risk

K240458 is an FDA 510(k) clearance for the Synthetic Bone Putty. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Ventris Medical (Newport Beach, US). The FDA issued a Cleared decision on March 7, 2024 after a review of 20 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 Ventris Medical devices

Submission Details

510(k) Number K240458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2024
Decision Date March 07, 2024
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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

Bruder Consulting & Venture Group
Scott Bruder

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 K240458.
MagnetOs Putty
K240442 · Kuros Biosciences B.V · Apr 2024
NuVasive AttraX Scaffold
K240507 · Nuvasive, Inc. · Mar 2024
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix
K240424 · Collagen Matrix, Inc. · Mar 2024
NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)
K240404 · Novabone Products, LLC · Mar 2024
Cerament Bone Void Filler
K240459 · Bonesupport AB · Mar 2024
ReBOSSIS
K240453 · Orthorebirth Co., Ltd. · Mar 2024