510(k) · Cleared
ClearedspineEOS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onefit Medical · LLZ System, Image Processing, Radiological
Cleared on Apr 8, 2016 as substantially equivalent to K141669 (Nemaris, Inc., 2014) after a 52-day review. Its family tree reaches back 10 generations to 1990. 6 later devices descend from it.
- Decided
- Apr 8, 2016
- Review
- 52 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K896095 (1990). 23 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations between
- 3 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 2 generations backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- 1 generation backK141669 SurgimapNemaris, Inc. · 2014
- This deviceK160407 spineEOSOnefit Medical · 2016
- Descendant · cites it directly · 5 of its ownK232086 spineEOSEos Imaging · 2023
- Descendant · 2 generations on · 4 of its ownK240582 VEA Align; spineEOSEos Imaging · 2024
- Descendant · 3 generations on · 1 of its ownK252103 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2025
- Descendant · 3 generations on · 1 of its ownK251747 VEA Align; spineEOSEos Imaging · 2025
- Descendant · 4 generations on · 0 of its ownK260322 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2026
Show all 10 generations
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 8 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 7 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 6 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 5 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 4 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 3 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 2 generations backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- 1 generation backK141669 SurgimapNemaris, Inc. · 2014
- This deviceK160407 spineEOSOnefit Medical · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K232086spineEOSEos Imaging · 2023 · cites it directly5descendants
- K240582VEA Align; spineEOSEos Imaging · 2024 · 2 generations on4descendants
- K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2025 · 3 generations on1descendant
- K251747VEA Align; spineEOSEos Imaging · 2025 · 3 generations on1descendant
- K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −9 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −8 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −7 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −6 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −5 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −4 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −3 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −2 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| −1 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
| 0 (this device) | K160407 | spineEOS | Onefit Medical | 2016 | — |
| +1 | K232086 | spineEOS | Eos Imaging | 2023 | — |
| +2 | K240582 | VEA Align; spineEOS | Eos Imaging | 2024 | — |
| +3 | K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2025 | — |
| +3 | K251747 | VEA Align; spineEOS | Eos Imaging | 2025 | — |
| +4 | K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2026 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K141669 | SurgimapSummary page 4…ion Name: Picture Archiving and Communication System (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ Predicate Device Surgimap 2.0 (K141669) by Nemaris Inc. Intended Use/Indications for Use Using 3D data and models obtained with sterEOS workstation, spineEOS… | 2014 |
| † | K152788 | EOS System | 2015 |
| † | K141137 | Stereos Workstation | 2014 |
| † | K142671 | Onefit Hip Planner | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232086 | spineEOS | 2023 | 5 |
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 26 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K232086 (Eos Imaging, 2023) has gone furthest, with 5 descendants of its own.
- 10 other devices also cite its predicate K141669.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Using 3D data and models obtained with sterEOS workstation, spineEOS software is indicated for assisting healthcare professionals in viewing, measuring images as well as in preoperative planning of spine surgeries. The device includes tools for measuring spine anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software online.
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/K160407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160407: spineEOS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160407
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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