Cleared Traditional

K171161 - Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)

K171161 is an FDA 510(k) clearance for Dimensional Bioceramics Calcium Sulfate..., manufactured by Dimensional Bioceramics, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K171161 · Dimensional Bioceramics, LLC · Orthopedic device
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Sep 2017
Decision
158d
Days
Class 2
Risk

K171161 is an FDA 510(k) clearance for the Dimensional Bioceramics Calcium Sulfate Device (DB-CSD). Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Dimensional Bioceramics, LLC (Scotts Valley, US). The FDA issued a Cleared decision on September 25, 2017 after a review of 158 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 Dimensional Bioceramics, LLC devices

FDA 510(k) Submission Details - K171161

510(k) Number K171161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2017
Decision Date September 25, 2017
Days to Decision 158 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
36d slower than avg
Panel avg: 122d · This submission: 158d
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

Trisler Consulting
Patsy J. Trisler

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 468
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