Cleared Traditional

K201535 - Cerament Bone Void Filler

K201535 is an FDA 510(k) clearance for Cerament Bone Void Filler, manufactured by Bonesupport AB. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K201535 · Bonesupport AB · Orthopedic device
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Oct 2020
Decision
130d
Days
Class 2
Risk

K201535 is an FDA 510(k) clearance for the Cerament Bone Void Filler. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Bonesupport AB (Lund, SE). The FDA issued a Cleared decision on October 16, 2020 after a review of 130 days - within the typical 510(k) review window.

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 Bonesupport AB devices

FDA 510(k) Submission Details - K201535

510(k) Number K201535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2020
Decision Date October 16, 2020
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
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 Peers - MQV Filler, Bone Void, Calcium Compound

All 292
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K201535.
DB-Composite
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K200507 · Wrightmedicaltechnologyinc · Oct 2020
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K200064 · SurGenTec, LLC · Aug 2020
CureOs TCP
K191670 · Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic · Aug 2020
Altapore MIS
K201464 · Baxter Healthcare Corporation · Jun 2020