510(k) · Cleared
ClearedStryker Custom TI Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Dec 16, 2005 as substantially equivalent to K043250 (Stryker Leibinger, 2005) and 1 other predicate after a 66-day review. Its family tree reaches back 2 generations to 1990. 18 later devices descend from it.
- Decided
- Dec 16, 2005
- Review
- 66 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K904111 (1990). 4 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 1 generation backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- This deviceK052871 Stryker Custom TI ImplantStryker Leibinger · 2005
- Descendant · cites it directly · 17 of its ownK062570 Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006
- Descendant · cites it directly · 13 of its ownK072707 Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007
- Descendant · 2 generations on · 8 of its ownK103582 Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 5 of its ownK121755 Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K062570Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006 · cites it directly17descendants
- K072707Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007 · cites it directly13descendants
- K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · 2 generations on8descendants
- K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012 · 2 generations on5descendants
- K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −1 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| 0 (this device) | K052871 | Stryker Custom TI Implant | Stryker Leibinger | 2005 | — |
| +1 | K062570 | Patient Contoured Mesh (PCM) | KLS-Martin L.P. | 2006 | — |
| +1 | K072707 | Patient Contoured Mesh-Peek (PCM-P) | KLS-Martin L.P. | 2007 | — |
| +2 | K103582 | Kelyniam Custom Skull Implant (Csi) | Kelyniam Global, Inc. | 2011 | 4 |
| +2 | K121755 | Custom Craniofacial Implant (Cci) | Kelyniam Global, Inc. | 2012 | — |
| +3 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K043250 | Stryker Patient Specific Polymer ImplantSummary page 1…customized implant. Substantial Equivalencv Intormation The Strvker® Custom Ti Implant is substantially equivalent to the Stryker Custom Cranial Implant (K043250) and Synthes (USA) Patient Specific Cranial/Craniofacial Implants (K033868). The Stryker Custom Ti Implants will be manufa… | 2005 |
| * | K033868 | Synthes (Usa) Patient Specific Cranial/Craniofacial ImplantsSummary page 1…om Ti Implant is substantially equivalent to the Stryker Custom Cranial Implant (K043250) and Synthes (USA) Patient Specific Cranial/Craniofacial Implants (K033868). The Stryker Custom Ti Implants will be manufactured using the same method as the Stryker Custom Cranial Implant (K043250… | 2004 |
What descends from it? (18)
See all 182 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 15 years and passes through 2 companies; a new generation was cleared every 14.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K062570 (KLS-Martin L.P., 2006) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K043250.
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.
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 Stryker®3 Custom Ti Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052871 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052871: Stryker Custom TI Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052871
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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