510(k) · Cleared
ClearedMedcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vanduzen Dba Medcad · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Jun 24, 2011 as substantially equivalent to K033868 (Synthes (Usa), 2004) and 1 other predicate after a 105-day review. Its family tree reaches back 3 generations to 1990. 11 later devices descend from it.
- Decided
- Jun 24, 2011
- Review
- 105 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904111 (1990). 6 ancestors in all, the oldest K873689 (1987). 11 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 2 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 1 generation backK072601 Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007
- This deviceK110684 Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial…Vanduzen Dba Medcad · 2011
- Descendant · cites it directly · 5 of its ownK121755 Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK220357 MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad · 2022
- Descendant · 3 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
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · 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 · 2 generations on4descendants
- K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad · 2022 · cites it directly2descendants
- K261058CraniUS PlateCraniUS, LLC · 2026 · 3 generations on1descendant
- K121818Osteofab Patient Specific Cranial DeviceOxford Performance Materials · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −2 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −1 | K072601 | Osteosymbionics Patient Specific Cranial Implant | Osteosymbionics, LLC | 2007 | — |
| 0 (this device) | K110684 | Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant | Vanduzen Dba Medcad | 2011 | — |
| +1 | K121755 | Custom Craniofacial Implant (Cci) | Kelyniam Global, Inc. | 2012 | — |
| +2 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019 | — |
| +1 | K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | Medcad | 2022 | — |
| +3 | K261058 | CraniUS Plate | CraniUS, LLC | 2026 | — |
| +1 | K121818 | Osteofab Patient Specific Cranial Device | Oxford Performance Materials | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 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 |
| 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 |
|---|---|---|---|
| * | K033868 | Synthes (Usa) Patient Specific Cranial/Craniofacial ImplantsSummary page 1…ccuShape™ PEEK Patient Specific Cranial Implant (PSCI) Patient Specific Cranial Implant (PSCI) Preformed nonalterable cranioplasty plate GXN Class I, 21 CFR 882.5330 K033868 — Synthes Patient Specific Cranial/Craniofacial Implants K072601 — OsteoSymbionics Patient-Specific Cranial Implant The MedCAD A… | 2004 |
| * | K072601 | Osteosymbionics Patient Specific Cranial ImplantSummary page 1…ecific Cranial Implant (PSCI) Preformed nonalterable cranioplasty plate GXN Class I, 21 CFR 882.5330 K033868 — Synthes Patient Specific Cranial/Craniofacial Implants K072601 — OsteoSymbionics Patient-Specific Cranial Implant The MedCAD AccuShape™ PEEK Patient Specific Cranial Implant devices are indiv… | 2007 |
What descends from it? (11)
See all 113 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 21 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K121755 (Kelyniam Global, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K033868.
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?
The MedCAD AccuShape™ PEEK Patient Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.
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/K110684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110684: Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110684
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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