Cleared Traditional

K160566 - Cerasorb Ortho Foam

K160566 is an FDA 510(k) clearance for Cerasorb Ortho Foam, manufactured by Curasan AG. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K160566 · Curasan AG · Orthopedic device
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Dec 2016
Decision
277d
Days
Class 2
Risk

K160566 is an FDA 510(k) clearance for the Cerasorb Ortho Foam. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Curasan AG (Kleinostheim, DE). The FDA issued a Cleared decision on December 2, 2016 after a review of 277 days - an extended review 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: 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 Curasan AG devices

FDA 510(k) Submission Details - K160566

510(k) Number K160566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date December 02, 2016
Days to Decision 277 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
155d slower than avg
Panel avg: 122d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

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

Yes Medical Device Services GmbH
Karin Lubbers

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 398
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K160566.
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