PEEK Customized Cranial Implant
FDA 510(k) K153248 · Stryker
510(k) numberK153248
Submission
- Device name
- PEEK Customized Cranial Implant
- Applicant
- Stryker
Portage, MI, US - Received
- November 9, 2015
- Decision date
- March 10, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GWO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262874 | CraniUS PlateGWO · Special | CraniUS, LLC | 09/11/2026SE |
| K261058 | CraniUS PlateGWO · Traditional | CraniUS, LLC | 07/29/2026SE |
| K250297 | TECHFIT Patient-Specific Cranial SystemGWO · Traditional | Techfit Digital Surgery, Inc. | 10/27/2025SE |
| K250334 | Fusion Craniofacial Implant; Fusion Skull ImplantGWO · Traditional | Kelyniam Global, Inc. | 07/25/2025SE |
| K231834 | VSP PEEK Cranial ImplantGWO · Traditional | 3D Systems, Inc. | 04/04/2024SE |
| K212391 | MCI-Neuro Fixation SystemGWO · Traditional | Mci Medical Concept Innovation, Inc. | 10/21/2022SE |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro…GWO · Traditional | Osteonic Co., Ltd. | 01/27/2022SE |
| K203055 | Stryker PEEK Customized Cranial Implant KitGWO · Traditional | Stryker | 02/09/2021SE |
| K190811 | Optimus NEURO System - Sterile KitGWO · Traditional | Osteonic Co., Ltd. | 11/27/2019SE |
| K190229 | Stryker PEEK Customized Cranial Implant KitGWO · Traditional | Stryker | 07/11/2019SE |
More from Stryker
| 510(k) | Device | Decision |
|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | 06/29/2026SE |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemHSB · Traditional | 02/03/2026SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | 12/19/2025SE |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemHSB · Traditional | 08/20/2025SE |
| K250163 | T2 Alpha Femur Retrograde Nailing SystemHSB · Traditional | 08/13/2025SE |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…HRS · Traditional | 10/06/2024SE |
| K233919 | VariAx 2 Distal Radius SystemHRS · Traditional | 03/25/2024SE |
| K233741 | Hoffmann LRF SystemKTT · Special | 12/21/2023SE |
| K230045 | HipCheckQIH · Traditional | 09/29/2023SE |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMOWN · Traditional | 09/20/2023SE |
Questions and answers
When was PEEK Customized Cranial Implant cleared by the FDA?
PEEK Customized Cranial Implant (K153248) received a 510(k) decision of Substantially Equivalent on March 10, 2016, 122 days after the submission was received.
What is the product code of K153248?
The FDA product code is GWO – Plate, Cranioplasty, Preformed, Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5320.