510(k) · Cleared
ClearedFusion Craniofacial Implant; Fusion Skull Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kelyniam Global, Inc. · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Jul 25, 2025 as substantially equivalent to K103582 (Kelyniam Global, Inc., 2011) and 2 other predicates after a 170-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Jul 25, 2025
- Review
- 170 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K904111 (1990). 20 ancestors in all, the oldest K832283 (1984). No later device cites it as a predicate yet.
- Root · 8 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 7 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 6 generations backK052871 Stryker Custom TI ImplantStryker Leibinger · 2005
- 5 generations backK062570 Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006
- 4 generations backK072707 Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007
- 3 generations backK103582 Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · Recalled
- 2 generations backK121755 Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012
- 1 generation backK182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019
- This deviceK250334 Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −7 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −6 | K052871 | Stryker Custom TI Implant | Stryker Leibinger | 2005 | — |
| −5 | K062570 | Patient Contoured Mesh (PCM) | KLS-Martin L.P. | 2006 | — |
| −4 | K072707 | Patient Contoured Mesh-Peek (PCM-P) | KLS-Martin L.P. | 2007 | — |
| −3 | K103582 | Kelyniam Custom Skull Implant (Csi) | Kelyniam Global, Inc. | 2011 | 4 |
| −2 | K121755 | Custom Craniofacial Implant (Cci) | Kelyniam Global, Inc. | 2012 | — |
| −1 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019 | — |
| 0 (this device) | K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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 GWO? 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 GWO device
- #1 K261058 CraniUS Platescore 16.8 · 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 |
|---|---|---|---|
| * | K103582 | Kelyniam Custom Skull Implant (Csi)Summary page 5…/ Product Code: GWO / Classification: Class II in accordance with 21 CFR 882.5320, Preformed Alterable Cranioplasty Plate. Predicate Devices: • Primary Predicates - K103582 Kelyniam Global Inc. (KGI) Customized Skull Implant (CSI); K121755 Kelyniam Global Inc. (KGI) Customized Craniofacial Im… | 2011 |
| * | K121755 | Custom Craniofacial Implant (Cci)Summary page 5…2.5320, Preformed Alterable Cranioplasty Plate. Predicate Devices: • Primary Predicates - K103582 Kelyniam Global Inc. (KGI) Customized Skull Implant (CSI); K121755 Kelyniam Global Inc. (KGI) Customized Craniofacial Implant (CCI); K182711 Kelyniam Global Inc. (KGI) Customized Craniofa… | 2012 |
| * | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Summary page 5…rimary Predicates - K103582 Kelyniam Global Inc. (KGI) Customized Skull Implant (CSI); K121755 Kelyniam Global Inc. (KGI) Customized Craniofacial Implant (CCI); K182711 Kelyniam Global Inc. (KGI) Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI). Device Descr… | 2019 |
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 35 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 20 ancestors have a recall of any class.
- 3 other devices also cite its predicate K103582.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GWO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWO
196in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWO
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWO
237in 2025
MAUDE reports naming product code GWO, 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 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 5 | 133 | 0 | 5 |
| 2013 | 4 | 249 | 0 | 7 |
| 2014 | 3 | 109 | 0 | 11 |
| 2015 | 3 | 210 | 2 | 18 |
| 2016 | 3 | 125 | 0 | 18 |
| 2017 | 2 | — | 0 | 47 |
| 2018 | 1 | — | 0 | 41 |
| 2019 | 4 | 196 | 0 | 14 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 2 | — | 0 | 53 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 1 | — | 0 | 149 |
| 2025 | 2 | — | 0 | 237 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are intended to fill a bony void or defect area in a patient’s specific cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250334: Fusion Craniofacial Implant; Fusion Skull Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250334
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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