510(k) · Cleared
ClearedOSSDSIGN Cranial PSI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ossdsign AB · PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty
Cleared on Oct 1, 2021 as substantially equivalent to K161090 (Ossdsign AB, 2017) after a 59-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Oct 1, 2021
- Review
- 59 days
- Class
- Class II
- Product code
- PJN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904111 (1990). 9 ancestors in all, the oldest K832283 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 4 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 3 generations backK052871 Stryker Custom TI ImplantStryker Leibinger · 2005
- 2 generations backK062570 Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006
- 1 generation backK161090 Cranial PSIOssdsign AB · 2017
- This deviceK212414 OSSDSIGN Cranial PSIOssdsign AB · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −4 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −3 | K052871 | Stryker Custom TI Implant | Stryker Leibinger | 2005 | — |
| −2 | K062570 | Patient Contoured Mesh (PCM) | KLS-Martin L.P. | 2006 | — |
| −1 | K161090 | Cranial PSI | Ossdsign AB | 2017 | — |
| 0 (this device) | K212414 | OSSDSIGN Cranial PSI | Ossdsign AB | 2021 | — |
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 |
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 PJN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K161090 | Cranial PSISummary page 4…. Classification Name: Plate, Preformed Non-alterable Cranioplasty Plate (21 CFR 882.5330, Product code: PJN) 7. Class: 2 8. Predicate Device: OSSDSIGN Cranial PSI (K161090) 9. Device Description: OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial… | 2017 |
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 31 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K161090.
How does its category compare?
All PJN devicesPJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PJN
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PJN
Too few PJN 510(k)s in any year since 2007 to give a median.
Recalls per year · PJN
No recall names PJN since 2007.
Adverse event reports per year · PJN
1in 2025
MAUDE reports naming product code PJN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212414: OSSDSIGN 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/K212414
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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