510(k) · Cleared
ClearedMedCAD AccuShape Titanium Patient-Specific Cranial Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcad · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Aug 26, 2022 as substantially equivalent to K110684 (Vanduzen Dba Medcad, 2011) and 1 other predicate after a 199-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Aug 26, 2022
- Review
- 199 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904111 (1990). 9 ancestors in all, the oldest K832283 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 3 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 2 generations backK072601 Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007
- 1 generation backK110684 Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial…Vanduzen Dba Medcad · 2011
- This deviceK220357 MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad · 2022
- Descendant · cites it directly · 0 of its ownK252251 Easymade-TICG Bio Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243715 Synthes Patient Specific ImplantsSynthes GmbH · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −3 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −2 | K072601 | Osteosymbionics Patient Specific Cranial Implant | Osteosymbionics, LLC | 2007 | — |
| −1 | K110684 | Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant | Vanduzen Dba Medcad | 2011 | — |
| 0 (this device) | K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | Medcad | 2022 | — |
| +1 | K252251 | Easymade-TI | CG Bio Co., Ltd. | 2026 | — |
| +1 | K243715 | Synthes Patient Specific Implants | Synthes GmbH | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K110684 | Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial ImplantSummary page 4…alterable cranioplasty plate (21 CFR Code – 882.5330) Classification Regulatory Class: II Product Code: GXN K110684 MedCAD® AccuShape® PEEK Patient Specific Cranial Predicate Device Implant K053199 Synth… | 2011 |
| * | K053199 | Synthes Patient Specific Cranial/Craniofacial ImplantSummary page 4…Product Code: GXN K110684 MedCAD® AccuShape® PEEK Patient Specific Cranial Predicate Device Implant K053199 Synthes Patient Specific Cranial Implant Reference Device K193280 MedCAD® AccuPlate® Patient-Specific Plate… | 2005 |
| † | K193280 | MedCAD® AccuPlate® Patient-Specific Plate | 2021 |
| † | K192282 | MedCAD® AccuPlan® System | 2020 |
What descends from it? (2)
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 32 years and passes through 5 companies; a new generation was cleared every 11.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K252251 (CG Bio Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K110684.
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. 2022, 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 Titanium 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/K220357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220357: MedCAD AccuShape Titanium Patient-Specific Cranial Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220357
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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