510(k) · Cleared
Cleared3D MAC Titanium Cranial Plate (TCP) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Surgeon General, Department of the Army (TSG-DA) · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Jun 18, 2026 as substantially equivalent to K151692 (Bioarchitects USA, LLC, 2015) after a 267-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Jun 18, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K832283 (1984). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK832283 Medpar Surgical ImplantsPorex Medical · 1984
- 2 generations backK053199 Synthes Patient Specific Cranial/Craniofacial ImplantSynthes (Usa) · 2005
- 1 generation backK151692 BioArchitects Patient Specific Cranial/Craniofacial PlateBioarchitects USA, LLC · 2015
- This deviceK253116 3D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA) · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K832283 | Medpar Surgical Implants | Porex Medical | 1984 | — |
| −2 | K053199 | Synthes Patient Specific Cranial/Craniofacial Implant | Synthes (Usa) | 2005 | — |
| −1 | K151692 | BioArchitects Patient Specific Cranial/Craniofacial Plate | Bioarchitects USA, LLC | 2015 | — |
| 0 (this device) | K253116 | 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 GXN? 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 GXN device
- #1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 8 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 |
|---|---|---|---|
| * | K151692 | BioArchitects Patient Specific Cranial/Craniofacial PlateSummary page 5….5330 Product Code: GXN Predicate Device Information Predicate Device BioArchitects Patient Specific Cranial/Craniofacial Plate (K151692) Name: Classification: 21 CFR 882.5330 Product Code: GXN Device Description The 3D MAC Titanium Cranial P… | 2015 |
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 42 years and passes through 4 companies; a new generation was cleared every 10.6 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K151692.
How does its category compare?
All GXN devicesGXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GXN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXN
69in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXN
24in 2025
MAUDE reports naming product code GXN, 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 | 2 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 23 |
| 2011 | 2 | — | 0 | 20 |
| 2012 | 3 | 102 | 0 | 29 |
| 2013 | 1 | — | 0 | 57 |
| 2014 | 2 | — | 0 | 60 |
| 2015 | 2 | — | 0 | 47 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 74 |
| 2018 | 3 | 199 | 6 | 56 |
| 2019 | 0 | — | 0 | 54 |
| 2020 | 5 | 33 | 0 | 63 |
| 2021 | 3 | 69 | 0 | 63 |
| 2022 | 2 | — | 0 | 57 |
| 2023 | 1 | — | 0 | 32 |
| 2024 | 1 | — | 0 | 35 |
| 2025 | 2 | — | 0 | 24 |
| 2026 | 4 | 193 | 0 | — |
What is it indicated for?
The 3D MAC Titanium Cranial Plate (TCP) System is a patient-specific device that is indicated for use to replace bony voids in the cranial and/or craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, sphenoid bone, ethmoid process, vomer).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253116: 3D MAC Titanium Cranial Plate (TCP) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253116
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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