510(k) · Cleared
ClearedBioArchitects Patient Specific Cranial/Craniofacial Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioarchitects USA, LLC · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Nov 20, 2015 as substantially equivalent to K053199 (Synthes (Usa), 2005) after a 150-day review. Its family tree reaches back 2 generations to 1984. 2 later devices descend from it.
- Decided
- Nov 20, 2015
- Review
- 150 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K832283 (1984). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK832283 Medpar Surgical ImplantsPorex Medical · 1984
- 1 generation backK053199 Synthes Patient Specific Cranial/Craniofacial ImplantSynthes (Usa) · 2005
- This deviceK151692 BioArchitects Patient Specific Cranial/Craniofacial PlateBioarchitects USA, LLC · 2015
- Descendant · cites it directly · 0 of its ownK253116 3D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA) · 2026
- Descendant · cites it directly · 0 of its ownK252251 Easymade-TICG Bio Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K832283 | Medpar Surgical Implants | Porex Medical | 1984 | — |
| −1 | K053199 | Synthes Patient Specific Cranial/Craniofacial Implant | Synthes (Usa) | 2005 | — |
| 0 (this device) | K151692 | BioArchitects Patient Specific Cranial/Craniofacial Plate | Bioarchitects USA, LLC | 2015 | — |
| +1 | K253116 | 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) | 2026 | — |
| +1 | K252251 | Easymade-TI | CG Bio Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K053199 | Synthes Patient Specific Cranial/Craniofacial ImplantSummary page 4…GALLY MARKETED DEVICE TO WHICH BIOARCHITECTS IS CLAIMING SUBSTANTIAL EQUIVALENCE: Primary Predicate Device: Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199). Reference Predicate Devices: Biomet HTR-PEKK Patient- Matched Implant (K121818) and Medtronic TiMesh Pre-Shaped Cranial Mes… | 2005 |
| † | K121818 | Osteofab Patient Specific Cranial Device | 2013 |
| † | K974017 | Timesh System | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 31 years and passes through 3 companies; a new generation was cleared every 21.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K253116 (The Surgeon General, Department of the Army (TSG-DA), 2026) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K053199.
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. 2015, 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 BioArchitects Patient Specific Cranial/Craniofacial Plate implant device is intended 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). It is a patient specific device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151692: BioArchitects Patient Specific Cranial/Craniofacial Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151692
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026