510(k) · Cleared
Recalled · Class II · 2017Kelyniam Custom Skull Implant (Csi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kelyniam Global, Inc. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Apr 14, 2011 as substantially equivalent to K053199 (Synthes (Usa), 2005) and 2 other predicates after a 127-day review. Its family tree reaches back 5 generations to 1990. 8 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 14, 2011
- Review
- 127 days
- Class
- Class II
- Product code
- GXN
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 5 generations to K904111 (1990). 11 ancestors in all, the oldest K832283 (1984). 8 later devices descend from it, 4 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 deviceK103582 Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK121755 Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK261058 CraniUS PlateCraniUS, LLC · 2026
- Descendant · cites it directly · 1 of its ownK121818 Osteofab Patient Specific Cranial DeviceOxford Performance Materials · 2013
- Descendant · 3 generations on · 0 of its ownK262874 CraniUS PlateCraniUS, LLC · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012 · cites it directly5descendants
- K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019 · cites it directly4descendants
- K261058CraniUS PlateCraniUS, LLC · 2026 · 2 generations on1descendant
- K121818Osteofab Patient Specific Cranial DeviceOxford Performance Materials · 2013 · cites it directly1descendant
- K262874CraniUS PlateCraniUS, LLC · 2026 · 3 generations on0descendants
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 | K072707 | Patient Contoured Mesh-Peek (PCM-P) | KLS-Martin L.P. | 2007 | — |
| 0 (this device) | K103582 | Kelyniam Custom Skull Implant (Csi) | Kelyniam Global, Inc. | 2011 | — |
| +1 | K121755 | Custom Craniofacial Implant (Cci) | Kelyniam Global, Inc. | 2012 | — |
| +1 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019 | — |
| +2 | K261058 | CraniUS Plate | CraniUS, LLC | 2026 | — |
| +1 | K121818 | Osteofab Patient Specific Cranial Device | Oxford Performance Materials | 2013 | — |
| +3 | K262874 | CraniUS Plate | CraniUS, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K053199 | Synthes Patient Specific Cranial/Craniofacial ImplantSummary page 2…brospinal fluid. Substantial Equivalence: The Kelyniam Custom Skull Implants (CSI) are substantially equivalent to the Synthes Patient Specific Cranial Implant (PSCI) (K053199), OsteoSymbionics Patient-Specific Cranial Implant (K072601) and KLS Martin Patient Contoured Mesh (K072707). Like these other de… | 2005 |
| * | K072601 | Osteosymbionics Patient Specific Cranial ImplantSummary page 2…tom Skull Implants (CSI) are substantially equivalent to the Synthes Patient Specific Cranial Implant (PSCI) (K053199), OsteoSymbionics Patient-Specific Cranial Implant (K072601) and KLS Martin Patient Contoured Mesh (K072707). Like these other devices, the Kelyniam Custom Skull Implant (CSI) is manufactur… | 2007 |
| * | K072707 | Patient Contoured Mesh-Peek (PCM-P)Summary page 2…alent to the Synthes Patient Specific Cranial Implant (PSCI) (K053199), OsteoSymbionics Patient-Specific Cranial Implant (K072601) and KLS Martin Patient Contoured Mesh (K072707). Like these other devices, the Kelyniam Custom Skull Implant (CSI) is manufactured from PEEK or equivalent polymers, sold non-st… | 2007 |
What descends from it? (8)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2017 | Class II | Z-1872-2018 | Device Design | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to… |
| Jun 10, 2017 | Class II | Z-1871-2018 | Device Design | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to… |
| Jun 10, 2017 | Class II | Z-1873-2018 | Device Design | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to… |
| Jun 10, 2017 | Class II | Z-1870-2018 | Device Design | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K121755 (Kelyniam Global, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 10 other devices also cite its predicate K053199.
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. 2011, 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?
Patient Specific Cranial implants are intended for the replacement of bony voids in the cranial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103582 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103582: Kelyniam Custom Skull Implant (Csi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103582
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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