Class Class II
Akunah REFLECT (K222987)
Description
Akunah REFLECT by Akunah Pty, Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222987
Clearance Date2023-05-10
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222987
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Akunah REFLECT (K222987) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212569 | Materialise Shoulder System™, Materialise Shoulder Guide an... | Materialise NV | 2022 |
| K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 |
| K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCas... | Materialise NV | 2020 |
| K183105 | Mimics Medical | Materialise NV | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243765 | LuMon(TM) System | Sentec AG | 2025 |
Trace the full predicate network for K222987
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.