510(k) · Cleared
ClearedMyPAO Planning Report
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · LLZ System, Image Processing, Radiological
Cleared on Feb 19, 2021 as substantially equivalent to K162559 (Biomet, Inc., 2017) after a 350-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Feb 19, 2021
- Review
- 350 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924630 (1993). 7 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK073468 MimicsMaterialise NV · 2008
- 2 generations backK132636 Dyonics Plan Hip Impingement Planning SystemSmith & Nephew, Inc. · 2013
- 1 generation backK162559 Move Forward 3D Motion Simulation ServiceBiomet, Inc. · 2017
- This deviceK200589 MyPAO Planning ReportMedacta International S.A. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K073468 | Mimics | Materialise NV | 2008 | — |
| −2 | K132636 | Dyonics Plan Hip Impingement Planning System | Smith & Nephew, Inc. | 2013 | — |
| −1 | K162559 | Move Forward 3D Motion Simulation Service | Biomet, Inc. | 2017 | — |
| 0 (this device) | K200589 | MyPAO Planning Report | Medacta International S.A. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K162559 | Move Forward 3D Motion Simulation ServiceSummary page 4…assification II III. Predicate Device Substantial equivalence is claimed to the following device: x Move Forward 3D Motion Simulation Service, K162559, Biomet Inc. IV. Device Description MyPAO uses the patients’ CT scan to segment the patient’s bones in order to provide… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K162559.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Medacta MyPAO surgical planning report is intended to provide users with patient’s pre-operative information and an estimation of the post-operative parameters after the realignment of the acetabulum following the osteotomy. It is intended to be used for the pre-operative planning phase of Peri-Acetabular Osteotomy surgeries and it consists of a report in .pdf format elaborated on the basis of Patient’s Anatomical Data derived from the CT scan of the…
Read the full statement (140 words)
Medacta MyPAO surgical planning report is intended to provide users with patient’s pre-operative information and an estimation of the post-operative parameters after the realignment of the acetabulum following the osteotomy.
It is intended to be used for the pre-operative planning phase of Peri-Acetabular Osteotomy surgeries and it consists of a report in .pdf format elaborated on the basis of Patient’s Anatomical Data derived from the CT scan of the patient. The planning report is generated through a validated internal Medacta Manufacturing software and with a highly specialized engineering manual landmark selection.
The Medical Device, in accordance with a written prescription of the Surgeon, is intended for the sole use of the specific patient for which the case is created. Medacta MyPAO surgical planning is intended to be used on a skeletally mature population for which a PAO surgery is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200589: MyPAO Planning Report.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200589
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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