510(k) · Cleared
ClearedSurgimap (TM) Spine
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 30, 2011 as substantially equivalent to K073714 (Orthocrat, Ltd., 2008) after a 171-day review. Its family tree reaches back 8 generations to 1990. 51 later devices descend from it.
- Decided
- Sep 30, 2011
- Review
- 171 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 21 ancestors in all. 51 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 2 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 1 generation backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- This deviceK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- Descendant · cites it directly · 27 of its ownK141669 SurgimapNemaris, Inc. · 2014
- Descendant · cites it directly · 19 of its ownK163221 Mazor XMazor Robotics, Ltd. · 2017
- Descendant · 2 generations on · 17 of its ownK180307 Mazor XMazor Robotics, Ltd. · 2018
- Descendant · 3 generations on · 16 of its ownK182077 Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · Recalled
- Descendant · 4 generations on · 15 of its ownK200935 Mazor XMazor Robotics, Ltd. · 2020
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K141669SurgimapNemaris, Inc. · 2014 · cites it directly27descendants
- K163221Mazor XMazor Robotics, Ltd. · 2017 · cites it directly19descendants
- K180307Mazor XMazor Robotics, Ltd. · 2018 · 2 generations on17descendants
- K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd. · 2018 · 3 generations on16descendants
- K200935Mazor XMazor Robotics, Ltd. · 2020 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −2 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −1 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| 0 (this device) | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| +1 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
| +1 | K163221 | Mazor X | Mazor Robotics, Ltd. | 2017 | — |
| +2 | K180307 | Mazor X | Mazor Robotics, Ltd. | 2018 | — |
| +3 | K182077 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics, Ltd. | 2018 | 2 |
| +4 | K200935 | Mazor X | Mazor Robotics, Ltd. | 2020 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 10 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K073714 | Traumacad Version 2.0Summary page 1…892.2050 Class II Product Code: LLZ Predicate Device Tradename TraumaCad 2.0 5 10(k) number: K073714 Common Name: Picture Archiving and Communication System (PACS) Section: 892.2050 Class… | 2008 |
What descends from it? (51)
See all 514 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 21 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K141669 (Nemaris, Inc., 2014) has gone furthest, with 27 descendants of its own.
- 12 other devices also cite its predicate K073714.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Spine 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 spine related measurements
of the images, to plan surgical procedures (osteotomies), and includes toots for measuring
anatomical components for placement of surgical implants. Clinical judgment and
experience are required to properly use the software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111019: Surgimap (TM) Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111019
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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