510(k) · Cleared
ClearedSynthes Patient Specific Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes GmbH · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Nov 12, 2025 as substantially equivalent to K220357 (Medcad, 2022) after a 345-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Nov 12, 2025
- Review
- 345 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904111 (1990). 10 ancestors in all, the oldest K832283 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 4 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 3 generations backK072601 Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007
- 2 generations backK110684 Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial…Vanduzen Dba Medcad · 2011
- 1 generation backK220357 MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad · 2022
- This deviceK243715 Synthes Patient Specific ImplantsSynthes GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −4 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −3 | K072601 | Osteosymbionics Patient Specific Cranial Implant | Osteosymbionics, LLC | 2007 | — |
| −2 | K110684 | Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant | Vanduzen Dba Medcad | 2011 | — |
| −1 | K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | Medcad | 2022 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial ImplantSummary page 5…ation 882.5330 Preformed nonalterable cranioplasty plate. Product Code GXN: Plate, Cranioplasty, Preformed, Non-Alterable Predicate K220357 MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant Device(s) Reference K033868 / K053199 Synthes P… | 2022 |
| † | K033868 | Synthes (Usa) Patient Specific Cranial/Craniofacial Implants | 2004 |
| † | K053199 | Synthes Patient Specific Cranial/Craniofacial Implant | 2005 |
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 6 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K220357.
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. 2025, 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?
Patient Specific Implants are intended for the replacement of bony voids in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243715: Synthes Patient Specific Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243715
Report an extraction error
Are you the manufacturer?
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