Cleared Traditional

K200507 - PRO-DENSE LoVisc Bone Graft Substitute

K200507 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 233-day FDA review.

K200507 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
233d
Days
Class 2
Risk

K200507 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 October 21, 2020 after a review of 233 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K200507

510(k) Number K200507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date October 21, 2020
Days to Decision 233 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
111d slower than avg
Panel avg: 122d · This submission: 233d
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 398
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K200507.
si-Mochi
K202639 · Biostone, Ltd. · Apr 2021
DB-Composite
K210193 · Dimensional Bioceramics, LLC · Mar 2021
Uni-FuZe-P Bone Putty
K201781 · Zavation Medical Products, LLC · Dec 2020
Cerament Bone Void Filler
K201535 · Bonesupport AB · Oct 2020
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
K200064 · SurGenTec, LLC · Aug 2020
CureOs TCP
K191670 · Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic · Aug 2020