510(k) · Cleared
ClearedSectra Orthopedic Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sectra-Imtec AB · LLZ System, Image Processing, Radiological
Cleared on Oct 2, 2003 as substantially equivalent to K002936 (Sectra-Imtec AB, 2000) after a 134-day review. Its family tree reaches back 1 generation to 2000. 136 later devices descend from it.
- Decided
- Oct 2, 2003
- Review
- 134 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002936 (2000). 136 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK002936 Modification to IDS5 Image Display SystemSectra-Imtec AB · 2000
- This deviceK031590 Sectra Orthopedic PackageSectra-Imtec AB · 2003
- Descendant · cites it directly · 129 of its ownK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- Descendant · 2 generations on · 117 of its ownK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- Descendant · 3 generations on · 51 of its ownK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- Descendant · 3 generations on · 28 of its ownK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- Descendant · 3 generations on · 27 of its ownK141669 SurgimapNemaris, Inc. · 2014
Showing 5 of 136 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 136 · See all- K042816Traumacad 1.2Orthocrat, Ltd. · 2004 · cites it directly129descendants
- K073714Traumacad Version 2.0Orthocrat, Ltd. · 2008 · 2 generations on117descendants
- K111019Surgimap (TM) SpineNemaris, Inc. · 2011 · 3 generations on51descendants
- K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015 · 3 generations on28descendants
- K141669SurgimapNemaris, Inc. · 2014 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002936 | Modification to IDS5 Image Display System | Sectra-Imtec AB | 2000 | — |
| 0 (this device) | K031590 | Sectra Orthopedic Package | Sectra-Imtec AB | 2003 | — |
| +1 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| +2 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| +3 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| +3 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| +3 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 9 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 9 | 0 |
| 2023 | 11 | 0 |
| 2024 | 9 | 0 |
| 2025 | 23 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | K002936 | Modification to IDS5 Image Display System | 2000 |
What descends from it? (136)
See all 1365 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?
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 device is intended for the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.
Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031590: Sectra Orthopedic Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031590
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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