510(k) · Cleared
ClearedTnR Cranial Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
T&R BIOFAB CO., Ltd. · GXP Methyl Methacrylate For Cranioplasty
Cleared on Jul 30, 2026 as substantially equivalent to K051093 (Osteopore, Inc., 2006) after a 399-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Jul 30, 2026
- Review
- 399 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013966 (2002). 4 ancestors in all, the oldest K003015 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK013966 Apatight-TCP Bone Graft SubstituteCerabio, LLC · 2002
- 2 generations backK022629 WMT-TCP Bone Graft SubstituteWrightmedicaltechnologyinc · 2002
- 1 generation backK051093 Osteopore PCL ScaffoldOsteopore, Inc. · 2006 · Recalled
- This deviceK251959 TnR Cranial ImplantT&R BIOFAB CO., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013966 | Apatight-TCP Bone Graft Substitute | Cerabio, LLC | 2002 | — |
| −2 | K022629 | WMT-TCP Bone Graft Substitute | Wrightmedicaltechnologyinc | 2002 | — |
| −1 | K051093 | Osteopore PCL Scaffold | Osteopore, Inc. | 2006 | 1 |
| 0 (this device) | K251959 | TnR Cranial Implant | T&R BIOFAB CO., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXP device
- #1 K241027 Permatage Settable Bone Puttyscore 16.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051093 | Osteopore PCL ScaffoldSummary page 5…Information • Sponsor: Osteopore Inc. • Trade Name: Osteopore PCL Scaffold Bone Void Filler • Classification Name: Methyl methacrylate for cranioplasty • 510(k) Number: K051093 • Product Code: GXP • Regulation Number: 21 CFR 882.5300 • Regulation Class: Class II 510(k) Summary… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K051093.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GXP
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GXP
87in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXP
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXP
1in 2025
MAUDE reports naming product code GXP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 87 | 0 | 8 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 1 | 22 |
| 2010 | 1 | — | 0 | 59 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 1 | 28 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 1 | — | 2 | 9 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 4 | 85 | 0 | — |
What is it indicated for?
The TnR Cranial Implant is indicated for use in the repair of neurosurgical burr holes, craniotomy cuts, and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the cranial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251959 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251959: TnR Cranial Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251959
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026