510(k) · Cleared
ClearedPatient Contoured Implant-PEEK (PCI-PEEK)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS Martin L.P. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Nov 9, 2015 as substantially equivalent to K072707 (KLS-Martin L.P., 2007) after a 171-day review. Its family tree reaches back 5 generations to 1990. 2 later devices descend from it.
- Decided
- Nov 9, 2015
- Review
- 171 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904111 (1990). 9 ancestors in all, the oldest K832283 (1984). 2 later devices descend from it, 2 citing it directly.
- 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 backK072707 Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007
- This deviceK151382 Patient Contoured Implant-PEEK (PCI-PEEK)KLS Martin L.P. · 2015
- Descendant · cites it directly · 0 of its ownK252573 KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin…KLS-Martin L.P. · 2025
- Descendant · cites it directly · 0 of its ownK214109 PEEK Patient Specific Cranial/Craniofacial Implant (PSCI)Kontour (Xi’An) Medical Technology Co., Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −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 | K072707 | Patient Contoured Mesh-Peek (PCM-P) | KLS-Martin L.P. | 2007 | — |
| 0 (this device) | K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) | KLS Martin L.P. | 2015 | — |
| +1 | K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro… | KLS-Martin L.P. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K072707 | Patient Contoured Mesh-Peek (PCM-P)Summary page 4…reformed, Non-alterable Class II, 21 CFR 882.5330, Product Code GXN Predicate Devices: Patient Contoured Mesh – PEEK (PCM-P) [K072707] No reference devices were used in this submission. Device Description: The Patient Contoured Im… | 2007 |
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 25 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K252573 (KLS-Martin L.P., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K072707.
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 Patient Contoured Implant - PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151382: Patient Contoured Implant-PEEK (PCI-PEEK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151382
Report an extraction error
Are you the manufacturer?
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