Cleared Traditional

K212721 - Genex Bone Graft Substitute

K212721 is an FDA 510(k) clearance for Genex Bone Graft Substitute, manufactured by Biocomposites, Ltd.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K212721 · Biocomposites, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
161d
Days
Class 2
Risk

K212721 is an FDA 510(k) clearance for the Genex Bone Graft Substitute. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on February 4, 2022 after a review of 161 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 Biocomposites, Ltd. devices

FDA 510(k) Submission Details - K212721

510(k) Number K212721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2021
Decision Date February 04, 2022
Days to Decision 161 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
39d slower than avg
Panel avg: 122d · This submission: 161d
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 399
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K212721.
FIBERGRAFT Aeridyan Matrix Bone Graft Substitute
K213803 · Prosidyan, Inc. · Aug 2022
Mg OSTEOINJECT
K221256 · Bone Solutions, Inc. · Jun 2022
MagnetOs Flex Matrix
K213959 · Kuros Biosciences B.V · Apr 2022
Osteorevive
K212991 · Bone Solutions, Inc. · Jan 2022
MagnetOs granules
K213111 · Kuros Biosciences B.V · Jan 2022
PRO-DENSE LoVisc Bone Graft Substitute
K213342 · Wrightmedicaltechnologyinc · Jan 2022