Cleared Traditional

GaiaBone Bioabsorbable Bone Graft (K220337) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220337 · Corliber (Shenzhen) Medical Device Co., Ltd. · Orthopedic device
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Feb 2023
Decision
361d
Days
Class 2
Risk

K220337 is an FDA 510(k) clearance for the GaiaBone Bioabsorbable Bone Graft. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Corliber (Shenzhen) Medical Device Co., Ltd. (Shenzhen City, CN). The FDA issued a Cleared decision on February 3, 2023 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Corliber (Shenzhen) Medical Device Co., Ltd. devices

Submission Details

510(k) Number K220337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2022
Decision Date February 03, 2023
Days to Decision 361 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
239d slower than avg
Panel avg: 122d · This submission: 361d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Cosmos Biomed Consulting Co., Ltd.
Li-Ting Lu

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 201
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K220337.
Bonalive Orthopedics granules
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K223915 · Anika Therapeutics, Inc. · Mar 2023
DSM Biomedical Calcium Phosphate Cement
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MONTAGE Settable, Resorbable Bone Putty
K222063 · Orthocon, Inc. · Feb 2023
OsteoCNX
K223563 · Converg Engineering · Jan 2023
Uni-FuZe-C Bone Strip
K221726 · Zavation Medical Products, LLC · Jan 2023