510(k) · Cleared
ClearedCranial PSI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ossdsign AB · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Jan 19, 2017 as substantially equivalent to K062570 (KLS-Martin L.P., 2006) after a 276-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Jan 19, 2017
- Review
- 276 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904111 (1990). 8 ancestors in all, the oldest K832283 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 3 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 2 generations backK052871 Stryker Custom TI ImplantStryker Leibinger · 2005
- 1 generation backK062570 Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006
- This deviceK161090 Cranial PSIOssdsign AB · 2017
- Descendant · cites it directly · 0 of its ownK212414 OSSDSIGN Cranial PSIOssdsign AB · 2021
- Descendant · cites it directly · 0 of its ownK190523 Cranial PSI Accessory – Anatomical Model Original, Cranial PSI…Ossdsign AB · 2019
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 |
|---|---|---|---|---|---|
| −4 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −3 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −2 | K052871 | Stryker Custom TI Implant | Stryker Leibinger | 2005 | — |
| −1 | K062570 | Patient Contoured Mesh (PCM) | KLS-Martin L.P. | 2006 | — |
| 0 (this device) | K161090 | Cranial PSI | Ossdsign AB | 2017 | — |
| +1 | K212414 | OSSDSIGN Cranial PSI | Ossdsign AB | 2021 | — |
| +1 | K190523 | Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory –… | Ossdsign AB | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K062570 | Patient Contoured Mesh (PCM)Summary page 4…d Non-alterable Cranioplasty Plate (21 CFR 882.5330, Product code: PJN) 7. Class: 2 8. Substantially equivalent to: KLS Martin – Patient Contoured Mesh (K062570) 9. Device Description: OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the… | 2006 |
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 27 years and passes through 4 companies; a new generation was cleared every 10.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K212414 (Ossdsign AB, 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K062570.
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. 2017, 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?
OSSDSIGN Cranial PSI is intended for the reconstruction of cranial defects. It is indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161090: Cranial PSI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161090
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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