510(k) · Cleared
ClearedPEEK Patient Specific Cranial/Craniofacial Implant (PSCI)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kontour (Xi’An) Medical Technology Co., Ltd. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Oct 28, 2022 as substantially equivalent to K151382 (KLS Martin L.P., 2015) after a 303-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Oct 28, 2022
- Review
- 303 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904111 (1990). 10 ancestors in all, the oldest K832283 (1984). No later device cites it as a predicate yet.
- Root · 6 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 5 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 4 generations backK052871 Stryker Custom TI ImplantStryker Leibinger · 2005
- 3 generations backK062570 Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006
- 2 generations backK072707 Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007
- 1 generation backK151382 Patient Contoured Implant-PEEK (PCI-PEEK)KLS Martin L.P. · 2015
- This deviceK214109 PEEK Patient Specific Cranial/Craniofacial Implant (PSCI)Kontour (Xi’An) Medical Technology Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −5 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −4 | K052871 | Stryker Custom TI Implant | Stryker Leibinger | 2005 | — |
| −3 | K062570 | Patient Contoured Mesh (PCM) | KLS-Martin L.P. | 2006 | — |
| −2 | K072707 | Patient Contoured Mesh-Peek (PCM-P) | KLS-Martin L.P. | 2007 | — |
| −1 | K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) | KLS Martin L.P. | 2015 | — |
| 0 (this device) | K214109 | PEEK Patient Specific Cranial/Craniofacial Implant (PSCI) | Kontour (Xi’An) Medical Technology Co., Ltd. | 2022 | — |
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 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.
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 32 years and passes through 5 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K151382.
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. 2022, 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 PEEK Patient Specific Cranial/Craniofacial Implant (PSCI) is intended to replace bony voids in the cranial and/or craniofacial skeleton, excluding maxillofacial and /or oral regions.
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/K214109 · printed Nov 4, 2026
Cite this page
510(k) Report. “K214109: PEEK Patient Specific Cranial/Craniofacial Implant (PSCI).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K214109
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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