510(k) · Cleared
ClearedCustomized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
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 May 21, 2019 as substantially equivalent to K121153 (Stryker, 2012) and 3 other predicates after a 236-day review. Its family tree reaches back 7 generations to 1990. 4 later devices descend from it.
- Decided
- May 21, 2019
- Review
- 236 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K904111 (1990). 19 ancestors in all, the oldest K832283 (1984). 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 6 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 5 generations backK052871 Stryker Custom TI ImplantStryker Leibinger · 2005
- 4 generations backK062570 Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006
- 3 generations backK072707 Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007
- 2 generations backK103582 Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · Recalled
- 1 generation backK121755 Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012
- This deviceK182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK261058 CraniUS PlateCraniUS, LLC · 2026
- Descendant · 2 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 · cites it directly · 0 of its ownK231834 VSP PEEK Cranial Implant3D Systems, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K261058CraniUS PlateCraniUS, LLC · 2026 · cites it directly1descendant
- K262874CraniUS PlateCraniUS, LLC · 2026 · 2 generations on0descendants
- K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc. · 2025 · cites it directly0descendants
- K231834VSP PEEK Cranial Implant3D Systems, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −6 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −5 | K052871 | Stryker Custom TI Implant | Stryker Leibinger | 2005 | — |
| −4 | K062570 | Patient Contoured Mesh (PCM) | KLS-Martin L.P. | 2006 | — |
| −3 | K072707 | Patient Contoured Mesh-Peek (PCM-P) | KLS-Martin L.P. | 2007 | — |
| −2 | K103582 | Kelyniam Custom Skull Implant (Csi) | Kelyniam Global, Inc. | 2011 | 4 |
| −1 | K121755 | Custom Craniofacial Implant (Cci) | Kelyniam Global, Inc. | 2012 | — |
| 0 (this device) | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019 | — |
| +1 | K261058 | CraniUS Plate | CraniUS, LLC | 2026 | — |
| +2 | K262874 | CraniUS Plate | CraniUS, LLC | 2026 | — |
| +1 | K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. | 2025 | — |
| +1 | 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 |
| 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 16.9 · 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 |
|---|---|---|---|
| * | K121153 | Peek Customized Craial Implant KitSummary page 4…de: GWO / Classification: Class II in accordance with 21 CFR 882.5320, Information: Preformed Alterable Cranioplasty Plate • Primary Predicate - K121153 Stryker PEEK Customized Cranial Implant Kit Predicate • Secondary Predicate - K053199 Synthes Patient Specific Cranial/C… | 2012 |
| * | K053199 | Synthes Patient Specific Cranial/Craniofacial ImplantSummary page 4…ormed Alterable Cranioplasty Plate • Primary Predicate - K121153 Stryker PEEK Customized Cranial Implant Kit Predicate • Secondary Predicate - K053199 Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) Devices: • Tertiary Predicate - K103582 Kelyniam Global Inc… | 2005 |
| * | K103582 | Kelyniam Custom Skull Implant (Csi)Summary page 4…nial Implant Kit Predicate • Secondary Predicate - K053199 Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) Devices: • Tertiary Predicate - K103582 Kelyniam Global Inc. (KGI) Customized Skull Implant (CSI) • Quaternary Predicate - K121755 Kelyniam Global Inc.… | 2011 |
| * | K121755 | Custom Craniofacial Implant (Cci)Summary page 4…cial Implant (PSCI) Devices: • Tertiary Predicate - K103582 Kelyniam Global Inc. (KGI) Customized Skull Implant (CSI) • Quaternary Predicate - K121755 Kelyniam Global Inc. (KGI) Customized Craniofacial Implant (CCI) Customized Craniofacial Implant (CCI) and Cust… | 2012 |
What descends from it? (4)
3 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 29 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 19 ancestors have a recall of any class.
- Of its descendants, K261058 (CraniUS, LLC, 2026) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K121153.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) is intended to fill a bony void or defect area in a patient’s specific cranial and craniofacial skeleton (orbital rim, zygoma, & adjacent bone).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182711: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182711
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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