Cleared Traditional

Bonus Therapeutics Mixing and Delivery System (K190996) - FDA 510(k) Clearance

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

K190996 · Bonus Therapeutics , Ltd. · Orthopedic device
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Jul 2019
Decision
103d
Days
Class 2
Risk

K190996 is an FDA 510(k) clearance for the Bonus Therapeutics Mixing and Delivery System. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Bonus Therapeutics , Ltd. (Haifa, IL). The FDA issued a Cleared decision on July 28, 2019 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 880.5860 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Bonus Therapeutics , Ltd. devices

Submission Details

510(k) Number K190996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2019
Decision Date July 28, 2019
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 749
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