Cleared Traditional

K213342 - PRO-DENSE LoVisc Bone Graft Substitute

K213342 is an FDA 510(k) clearance for PRO-DENSE LoVisc Bone Graft Substitute, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K213342 · Wrightmedicaltechnologyinc · Orthopedic device
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Jan 2022
Decision
90d
Days
Class 2
Risk

K213342 is an FDA 510(k) clearance for the PRO-DENSE LoVisc Bone Graft Substitute. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on January 5, 2022 after a review of 90 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K213342

510(k) Number K213342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2021
Decision Date January 05, 2022
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 290
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K213342.
Genex Bone Graft Substitute
K212721 · Biocomposites, Ltd. · Feb 2022
Osteorevive
K212991 · Bone Solutions, Inc. · Jan 2022
MagnetOs granules
K213111 · Kuros Biosciences B.V · Jan 2022
ABCcolla Bone Matrix
K212156 · Acro Biomedical Co., Ltd. · Oct 2021
Dry DBM- A Putty
K212135 · Seaspine Corporation · Oct 2021
DB-EZ Bone Void Filler
K212353 · Dimensional Bioceramics, LLC · Sep 2021