Cleared Traditional

Sorrento Bioglass Bone Graft Substitute (K173933) - FDA 510(k) Clearance

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

K173933 · Xenco Medical, LLC · Orthopedic device
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Sep 2018
Decision
261d
Days
Class 2
Risk

K173933 is an FDA 510(k) clearance for the Sorrento Bioglass Bone Graft Substitute. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Xenco Medical, LLC (San Diego, US). The FDA issued a Cleared decision on September 13, 2018 after a review of 261 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 Xenco Medical, LLC devices

Submission Details

510(k) Number K173933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2017
Decision Date September 13, 2018
Days to Decision 261 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
139d slower than avg
Panel avg: 122d · This submission: 261d
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 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 K173933.
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K182823 · Wrightmedicaltechnologyinc · Nov 2018
Osteocera Resorbable Bone Substitute
K180758 · Wiltrom Corporation Limited · Oct 2018
Ceracell Ortho Foam
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BioSphere Flex
K173424 · Synergy Biomedical · Sep 2018
PRODENSE Bone Graft Substitute
K181255 · Wrightmedicaltechnologyinc · Sep 2018
ALTAPORE
K181225 · Baxter Healthcare Corporation · Aug 2018