Synthes Patient Specific Implants
FDA 510(k) K243715 · Synthes GmbH
510(k) numberK243715
Submission
- Device name
- Synthes Patient Specific Implants
- Applicant
- Synthes GmbH
Zuchwil, CH - Received
- December 2, 2024
- Decision date
- November 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXN
| 510(k) | Device | Applicant | Decision |
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| K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring…GXN · Traditional | Longeviti Neuro Solutions | 06/25/2026SE |
| K253116 | 3D MAC Titanium Cranial Plate (TCP) SystemGXN · Traditional | The Surgeon General, Department of the Army… | 06/18/2026SE |
| K252251 | Easymade-TiGXN · Traditional | CG Bio Co., Ltd. | 04/09/2026SE |
| K252958 | METICULY Patient-specific titanium mesh implantGXN · Traditional | Meticuly Co., Ltd. | 01/14/2026SE |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…GXN · Traditional | KLS-Martin L.P. | 11/10/2025SE |
| K240567 | CustomizedBone ServiceGXN · Special | Fin-Ceramica Faenza S.P.A. | 03/28/2024SE |
| K231920 | Longeviti ClearFit OTS Cranial ImplantGXN · Special | Longeviti Neuro Solutions, LLC | 11/09/2023SE |
| K214109 | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)GXN · Traditional | Kontour(XiAn) Medical Technology Co., Ltd. | 10/28/2022SE |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial ImplantGXN · Traditional | Medcad | 08/26/2022SE |
| K210099 | Meticuly Patient-Specific Titanium Mesh ImplantGXN · Traditional | Meticuly Co., Ltd. | 12/21/2021SE |
More from Meticuly Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating SystemHRS · Traditional | 03/10/2026SE |
| K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating SystemHRS · Traditional | 03/09/2026SE |
| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating SystemHRS · Traditional | 03/02/2026SE |
| K241927 | Synthes Graphic Case & Tray SystemKCT · Traditional | 03/28/2025SE |
| K233994 | VOLT Proximal Humerus 3.5 Plating SystemHRS · Traditional | 07/26/2024SE |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation SystemHRS · Traditional | 05/09/2024SE |
| K131792 | Synthecel Dura Repair, Synthecel Dura OnlayGXQ · Traditional | 12/16/2013SE |
| K123723 | Synthes Matrixneuro Cranial Plating SystemGWO · Traditional | 09/05/2013SE |
| K122455 | Synthes Small External Fixation System, Synthes Large External Fixation SystemKTT · Traditional | 04/11/2013SE |
| K122647 | Synthes Patient Specific PlateJEY · Traditional | 02/28/2013SE |
Questions and answers
When was Synthes Patient Specific Implants cleared by the FDA?
Synthes Patient Specific Implants (K243715) received a 510(k) decision of Substantially Equivalent on November 12, 2025, 345 days after the submission was received.
What is the product code of K243715?
The FDA product code is GXN – Plate, Cranioplasty, Preformed, Non-Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5330.