Cleared Traditional

K251959 - TnR Cranial Implant

K251959 is the FDA 510(k) clearance for TnR Cranial Implant by T&R BIOFAB CO., Ltd.. It is a Class 2 Neurology device (product code GXP) cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K251959 · T&R BIOFAB CO., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
399d
Days
Class 2
Risk

K251959 is an FDA 510(k) clearance for the TnR Cranial Implant. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by T&R BIOFAB CO., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on July 30, 2026 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all T&R BIOFAB CO., Ltd. devices

Submission Details

510(k) Number K251959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2025
Decision Date July 30, 2026
Days to Decision 399 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
251d slower than avg
Panel avg: 148d · This submission: 399d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXP Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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 Peers - GXP Methyl Methacrylate For Cranioplasty

All 25
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K251959.
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K241027 · Orthocon, Inc. · Sep 2024
Montage Flowable Settable, Resorbable Bone Paste
K232771 · Orthocon, Inc. · Feb 2024
MONTAGE-QS Settable, Resorbable Bone Putty
K231475 · Orthocon, Inc. · Oct 2023