Cleared Traditional

K181255 - PRODENSE Bone Graft Substitute

K181255 is an FDA 510(k) clearance for PRODENSE 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 124-day FDA review.

K181255 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
124d
Days
Class 2
Risk

K181255 is an FDA 510(k) clearance for the PRODENSE 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 September 12, 2018 after a review of 124 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 - K181255

510(k) Number K181255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2018
Decision Date September 12, 2018
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
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 468
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K181255.
Ceracell Ortho Foam
K181721 · Curasan AG · Sep 2018
Sorrento Bioglass Bone Graft Substitute
K173933 · Xenco Medical, LLC · Sep 2018
BioSphere Flex
K173424 · Synergy Biomedical · Sep 2018
ALTAPORE
K181225 · Baxter Healthcare Corporation · Aug 2018
CarriGen PF
K182107 · Etex Corporation · Aug 2018
Actifuse Flow
K181306 · Baxter Healthcare Corporation · Aug 2018