Cleared Traditional

K221606 - Absorbable Cranial Flap Fixation System (FDA 510(k) Clearance)

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

K221606 · Chendu Medart Medical Scientific Co., Ltd. · Neurology device
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Nov 2023
Decision
537d
Days
Class 2
Risk

K221606 is an FDA 510(k) clearance for the Absorbable Cranial Flap Fixation System. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Chendu Medart Medical Scientific Co., Ltd. (Chengdu, CN). The FDA issued a Cleared decision on November 21, 2023 after a review of 537 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Chendu Medart Medical Scientific Co., Ltd. devices

Submission Details

510(k) Number K221606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2022
Decision Date November 21, 2023
Days to Decision 537 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
389d slower than avg
Panel avg: 148d · This submission: 537d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
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 Neurology devices follow this clearance model.

Regulatory Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Joyce Yang

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.