510(k) · Cleared
ClearedAkunah REFLECT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Akunah Pty, Ltd. · LLZ System, Image Processing, Radiological
Cleared on May 10, 2023 as substantially equivalent to K183105 (Materialise NV, 2019) after a 224-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- May 10, 2023
- Review
- 224 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924630 (1993). 6 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 4 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 3 generations backK033849 Simplant SystemMaterialise NV · 2004
- 2 generations backK073468 MimicsMaterialise NV · 2008
- 1 generation backK183105 Mimics MedicalMaterialise NV · 2019
- This deviceK222987 Akunah REFLECTAkunah Pty, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK253674 Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.) · 2026
Most influential descendants
Showing 1 of 1 · See all- K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.) · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −4 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −3 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −2 | K073468 | Mimics | Materialise NV | 2008 | — |
| −1 | K183105 | Mimics Medical | Materialise NV | 2019 | — |
| 0 (this device) | K222987 | Akunah REFLECT | Akunah Pty, Ltd. | 2023 | — |
| +1 | K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K183105 | Mimics MedicalSummary page 4…icate Device Trade Name 510(k) number Decision Date Applicant Mimics Medical (PRIMARY PREDICATE) K183105 March 27, 2019 Materialise NV BLUEPRINTTM Patient Specific K203315… | 2019 |
| † | K203315 | BLUEPRINT™ Patient Specific Instrumentation | 2021 |
| † | K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253674 | Blueprint Patient-Specific Instrumentation | 2026 | 0 |
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 30 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K253674 (Stryker Corporation (Tornier, S.A.S.), 2026) has gone furthest, with 0 descendants of its own.
- 16 other devices also cite its predicate K183105.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222987 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222987: Akunah REFLECT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222987
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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