# K222987: Akunah REFLECT

- Pathway: 510(k) (Traditional)
- Applicant: Akunah Pty, Ltd.
- Decided: May 10, 2023 after 224 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924630 (1993). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183105: Mimics Medical, Materialise NV (2019) Summary page 4.

## Most influential descendants
- K253674: Blueprint Patient-Specific Instrumentation (2026), 0 descendants of its own

## Indications for use
Akunah Reflect Planning Software is intended to be used as a pre-surgical planner for shoulder arthroplasty, fracture, deformity correction and stabilisation procedures. The software is used to assist in the positioning of shoulder components. Akunah Reflect Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. The software leads to the generation of a planning report. The software is to be used for adult patients only and should not be used for diagnostic purposes. Akunah Reflect should be used in conjunction with expert clinical judgement.

Source page: https://510kreport.com/device/K222987
Methodology: https://510kreport.com/methodology