510(k) · Cleared
ClearedDyonics Plan Hip Impingement Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 17, 2013 as substantially equivalent to K073468 (Materialise NV, 2008) after a 56-day review. Its family tree reaches back 4 generations to 1993. 14 later devices descend from it.
- Decided
- Oct 17, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924630 (1993). 5 ancestors in all, the oldest K924810 (1993). 14 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 3 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 2 generations backK033849 Simplant SystemMaterialise NV · 2004
- 1 generation backK073468 MimicsMaterialise NV · 2008
- This deviceK132636 Dyonics Plan Hip Impingement Planning SystemSmith & Nephew, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK173390 hipEOSOnefit Medical · 2018
- Descendant · 2 generations on · 3 of its ownK212040 RI.Hip ModelerBlue Belt Technologies, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
- Descendant · cites it directly · 2 of its ownK162559 Move Forward 3D Motion Simulation ServiceBiomet, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK242272 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K173390hipEOSOnefit Medical · 2018 · cites it directly8descendants
- K212040RI.Hip ModelerBlue Belt Technologies, Inc. · 2022 · 2 generations on3descendants
- K192656Optimized Positioning System (OPS) InsightCorin USA · 2020 · 2 generations on3descendants
- K162559Move Forward 3D Motion Simulation ServiceBiomet, Inc. · 2017 · cites it directly2descendants
- K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −3 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −2 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −1 | K073468 | Mimics | Materialise NV | 2008 | — |
| 0 (this device) | K132636 | Dyonics Plan Hip Impingement Planning System | Smith & Nephew, Inc. | 2013 | — |
| +1 | K173390 | hipEOS | Onefit Medical | 2018 | — |
| +2 | K212040 | RI.Hip Modeler | Blue Belt Technologies, Inc. | 2022 | — |
| +2 | K192656 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | — |
| +1 | K162559 | Move Forward 3D Motion Simulation Service | Biomet, Inc. | 2017 | — |
| +3 | K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2024 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K073468 | MimicsSummary page 1…ially equivalent in Intended Use and Fundamental Scientiflc Technology to the following legally marketed device in commercial distribution: Mimics cleared in K073468. E. Description of Device The Smith & Nephew DYONICS PLAN Hip Impingement Planning System (here in a… | 2008 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K173390 (Onefit Medical, 2018) has gone furthest, with 8 descendants of its own.
- 8 other devices also cite its predicate K073468.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The DYONICS PLAN Hip Impingement Planning System software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review, respectively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132636: Dyonics Plan Hip Impingement Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132636
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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