510(k) · Cleared
ClearedCustom Craniofacial Implant (Cci)
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 Sep 25, 2012 as substantially equivalent to K103582 (Kelyniam Global, Inc., 2011) and 3 other predicates after a 102-day review. Its family tree reaches back 6 generations to 1990. 5 later devices descend from it.
- Decided
- Sep 25, 2012
- Review
- 102 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K904111 (1990). 13 ancestors in all, the oldest K832283 (1984). 5 later devices descend from it, 2 citing it directly.
- 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 backK103582 Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · Recalled
- This deviceK121755 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 · 3 generations on · 0 of its ownK262874 CraniUS PlateCraniUS, LLC · 2026
- Descendant · cites it directly · 0 of its ownK250334 Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK231834 VSP PEEK Cranial Implant3D Systems, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019 · cites it directly4descendants
- K261058CraniUS PlateCraniUS, LLC · 2026 · 2 generations on1descendant
- K262874CraniUS PlateCraniUS, LLC · 2026 · 3 generations on0descendants
- K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc. · 2025 · cites it directly0descendants
- K231834VSP PEEK Cranial Implant3D Systems, Inc. · 2024 · 2 generations on0descendants
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 | K103582 | Kelyniam Custom Skull Implant (Csi) | Kelyniam Global, Inc. | 2011 | 4 |
| 0 (this device) | 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 | — |
| +3 | K262874 | CraniUS Plate | CraniUS, LLC | 2026 | — |
| +1 | K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. | 2025 | — |
| +2 | K231834 | VSP PEEK Cranial Implant | 3D Systems, Inc. | 2024 | — |
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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K103582 | Kelyniam Custom Skull Implant (Csi)Summary page 2…Crpan(Sial __________ ___________(PCM-P) Ipat(SI number K103582 K053199 KO072707 K110684… | 2011 |
| * | K053199 | Synthes Patient Specific Cranial/Craniofacial ImplantSummary page 2…__________ ___________(PCM-P) Ipat(SI number K103582 K053199 KO072707 K110684… | 2005 |
| * | K072707 | Patient Contoured Mesh-Peek (PCM-P)Summary page 2…ustomized Skull Implant (CSI) (K1 03582), the Synthes Patient Specific Craniofacial Implant (PSCI) (K053 199), the KLS Martin L.P. Patient Contoured Mesh - PEEK (PCM-P) (K072707) and the MedCAD AccuShape PEEK Patient Specific Cranial Implant (PSCI) (KI 10684). For a complete list please reference the table… | 2007 |
| * | K110684 | Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial ImplantSummary page 2…_________(PCM-P) Ipat(SI number K103582 K053199 KO072707 K110684 Replace Co… | 2011 |
What descends from it? (5)
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 22 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K182711 (Kelyniam Global, Inc., 2019) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K103582.
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. 2012, 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 Kelyniam Customized Craniofacial Implant (CCI) is intended to correct bony voids in the Craniofacial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121755: Custom Craniofacial Implant (Cci).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121755
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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