Cleared Traditional

K221726 - Uni-FuZe-C Bone Strip

K221726 is an FDA 510(k) clearance for Uni-FuZe-C Bone Strip, manufactured by Zavation Medical Products, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K221726 · Zavation Medical Products, LLC · Orthopedic device
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Jan 2023
Decision
218d
Days
Class 2
Risk

K221726 is an FDA 510(k) clearance for the Uni-FuZe-C Bone Strip. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Zavation Medical Products, LLC (Flowood, US). The FDA issued a Cleared decision on January 18, 2023 after a review of 218 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 Zavation Medical Products, LLC devices

FDA 510(k) Submission Details - K221726

510(k) Number K221726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2022
Decision Date January 18, 2023
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
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 Consultant

BioVera, Inc.
Robert A Poggie

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K221726.
GaiaBone Bioabsorbable Bone Graft
K220337 · Corliber (Shenzhen) Medical Device Co., Ltd. · Feb 2023
MONTAGE Settable, Resorbable Bone Putty
K222063 · Orthocon, Inc. · Feb 2023
OsteoCNX
K223563 · Converg Engineering · Jan 2023
Mineral Collagen Composite Bioactive Moldable
K221735 · Collagen Matrix, Inc. · Dec 2022
Synthetic Bone Putty
K221644 · Ventris Medical · Sep 2022
FIBERGRAFT Aeridyan Matrix Bone Graft Substitute
K213803 · Prosidyan, Inc. · Aug 2022