Cleared Traditional

K180853 - EP Granules BVF

K180853 is an FDA 510(k) clearance for EP Granules BVF, manufactured by Elute, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K180853 · Elute, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
126d
Days
Class 2
Risk

K180853 is an FDA 510(k) clearance for the EP Granules™ BVF. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Elute, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 6, 2018 after a review of 126 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 Elute, Inc. devices

FDA 510(k) Submission Details - K180853

510(k) Number K180853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2018
Decision Date August 06, 2018
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 K180853.
ALTAPORE
K181225 · Baxter Healthcare Corporation · Aug 2018
CarriGen PF
K182107 · Etex Corporation · Aug 2018
Actifuse Flow
K181306 · Baxter Healthcare Corporation · Aug 2018
JGH1 Core Deccompression Procedure Kit
K181585 · AgNovos Healthcare USA, LLC · Jul 2018
JGH1 Bone Graft Substitute
K181342 · AgNovos Healthcare USA, LLC · Jul 2018
DSM Biomedical Calcium Phosphate Cement with Microspheres
K173572 · Kensey Nash Corporation Dba Dsm Biomedical · May 2018