510(k) · Cleared
ClearedTraumacad 1.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocrat, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Nov 10, 2004 as substantially equivalent to K032401 (Omsbar, Ltd., 2003) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1990. 129 later devices descend from it.
- Decided
- Nov 10, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K896095 (1990). 9 ancestors in all. 129 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 4 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 3 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 2 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 1 generation backK032401 OrthoviewOmsbar, Ltd. · 2003
- This deviceK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- Descendant · cites it directly · 117 of its ownK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- Descendant · 2 generations on · 51 of its ownK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- Descendant · 2 generations on · 28 of its ownK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- Descendant · 2 generations on · 27 of its ownK141669 SurgimapNemaris, Inc. · 2014
- Descendant · cites it directly · 21 of its ownK160284 JointPointJointpoint, Inc. · 2016
Showing 5 of 129 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 129 · See all- K073714Traumacad Version 2.0Orthocrat, Ltd. · 2008 · cites it directly117descendants
- K111019Surgimap (TM) SpineNemaris, Inc. · 2011 · 2 generations on51descendants
- K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015 · 2 generations on28descendants
- K141669SurgimapNemaris, Inc. · 2014 · 2 generations on27descendants
- K160284JointPointJointpoint, Inc. · 2016 · cites it directly21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −5 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −4 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −3 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −2 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −1 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| 0 (this device) | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| +1 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| +2 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| +2 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| +2 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
| +1 | K160284 | JointPoint | Jointpoint, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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? (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 |
|---|---|---|---|
| * | K032401 | OrthoviewSummary page 2…t Name 510(k) Classification Name Number Orthoview Meridian Technique Ltd K032401 Class II, Product code LLZ Sectra Orthopedic… | 2003 |
| * | K031590 | Sectra Orthopedic PackageSummary page 2…K032401 Class II, Product code LLZ Sectra Orthopedic Sectra lmtec AB K031590 Class II, Product Package code LLZ Additional Substantia… | 2003 |
What descends from it? (129)
See all 1295 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 14 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K073714 (Orthocrat, Ltd., 2008) has gone furthest, with 117 descendants of its own.
- 3 other devices also cite its predicate K032401.
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 TraumaCAD program is indicated for assisting healthcare professionals in
preoperative planning of orthopedic surgery. The device allows for overlaying
of prosthesis 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042816 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042816: Traumacad 1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042816
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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