510(k) · Cleared
ClearedSurgimap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nemaris, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 19, 2014 as substantially equivalent to K111019 (Nemaris, Inc., 2011) and 1 other predicate after an 88-day review. Its family tree reaches back 9 generations to 1990. 27 later devices descend from it.
- Decided
- Sep 19, 2014
- Review
- 88 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. 27 later devices descend from it, 11 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 backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- This deviceK141669 SurgimapNemaris, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK170172 UNiD Spine AnalyzerMedicrea International · 2017
- Descendant · 2 generations on · 6 of its ownK180091 UNiD Spine AnalyzerMedicrea International · 2018
- Descendant · cites it directly · 6 of its ownK160407 spineEOSOnefit Medical · 2016
- Descendant · 2 generations on · 5 of its ownK232086 spineEOSEos Imaging · 2023
- Descendant · 3 generations on · 4 of its ownK240582 VEA Align; spineEOSEos Imaging · 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 backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- This deviceK141669 SurgimapNemaris, Inc. · 2014
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K170172UNiD Spine AnalyzerMedicrea International · 2017 · cites it directly7descendants
- K180091UNiD Spine AnalyzerMedicrea International · 2018 · 2 generations on6descendants
- K160407spineEOSOnefit Medical · 2016 · cites it directly6descendants
- K232086spineEOSEos Imaging · 2023 · 2 generations on5descendants
- K240582VEA Align; spineEOSEos Imaging · 2024 · 3 generations on4descendants
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 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| 0 (this device) | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
| +1 | K170172 | UNiD Spine Analyzer | Medicrea International | 2017 | — |
| +2 | K180091 | UNiD Spine Analyzer | Medicrea International | 2018 | — |
| +1 | K160407 | spineEOS | Onefit Medical | 2016 | — |
| +2 | K232086 | spineEOS | Eos Imaging | 2023 | — |
| +3 | K240582 | VEA Align; spineEOS | Eos Imaging | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K111019 | Surgimap (TM) SpineSummary page 5…p Spine Manufacturer: Nemaris Inc Tradename: Surgimap Spine 510K #: K111019 (September 30, 2011) Common Name Picture Archiving and Communication System (PACS)… | 2011 |
| * | K073714 | Traumacad Version 2.0Summary page 5…urer: Voyant Health formerly known as Orthocrat Tradename: TraumaCad Release 2.0 510K #: K073714 (March 19, 2008) Common Name Picture Archiving and Communication System (PACS)… | 2008 |
What descends from it? (27)
See all 2711 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170172 | UNiD Spine Analyzer | 2017 | 7 |
| K160407 | spineEOS | 2016 | 6 |
| K162647 | NuVasive NuvaLine Mobile App | 2017 | 4 |
| K213975 | KEOPS Balance Analyzer 3D | 2022 | 2 |
| K211987 | ATEC Alignment App | 2021 | 2 |
| K223841 | KBA3D | 2023 | 1 |
| K221796 | Cyware 4H and Cysart 4H | 2022 | 1 |
| K171617 | OKI Surgical Planning Software | 2017 | 1 |
| K261861 | SPINEsim v1.0 | 2026 | 0 |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | 2025 | 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 24 years and passes through 6 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, K170172 (Medicrea International, 2017) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K111019.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Surgimap software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap users. Clinical judgment and experience are required to properly use the software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141669: Surgimap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141669
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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