510(k) · Cleared
ClearedOrthoNext Platform System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · LLZ System, Image Processing, Radiological
Cleared on Oct 27, 2020 as substantially equivalent to K142923 (Voyant Health, Ltd., 2015) and 1 other predicate after a 56-day review. Its family tree reaches back 9 generations to 1990. 1 later device descends from it.
- Decided
- Oct 27, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K896095 (1990). 22 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations between
- 3 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 2 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 1 generation backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- This deviceK202519 OrthoNext Platform SystemOrthofix Srl · 2020
- Descendant · cites it directly · 0 of its ownK242270 OrthoNext Platform SystemOrthofix Srl · 2024
Show all 9 generations
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 7 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 6 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 5 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 4 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 3 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 2 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 1 generation backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- This deviceK202519 OrthoNext Platform SystemOrthofix Srl · 2020
Most influential descendants
Showing 1 of 1 · See all- K242270OrthoNext Platform SystemOrthofix Srl · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −8 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −7 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −6 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −5 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −4 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −3 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −2 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −1 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| 0 (this device) | K202519 | OrthoNext Platform System | Orthofix Srl | 2020 | — |
| +1 | K242270 | OrthoNext Platform System | Orthofix Srl | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K142923 | TraumaCad Mobile Release 1.0Summary page 4…edicate Device 510(k) Manufacturer Number TraumaCad Mobile 1.0 K142923 ORTHOCRAT,LTD. 291Hillside Avenue… | 2015 |
| * | K073714 | Traumacad Version 2.0Summary page 4…Avenue Somerset, MA 02726 Additional Predicate Device TraumaCAD Version 2.0 K073714 ORTHOCRAT,LTD. 291Hillside Avenue… | 2008 |
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 |
|---|---|---|---|
| K242270 | OrthoNext Platform System | 2024 | 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 7 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K242270 (Orthofix Srl, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142923.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 OrthoNext ™ Platform system is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of Orthofix Product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.
The OrthoNext ™ Platform system is not to be used for mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202519: OrthoNext Platform System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202519
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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