510(k) · Cleared
ClearedOrtho-CMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medis Medical Imaging Systems BV · LLZ System, Image Processing, Radiological
Cleared on Jul 27, 2004 as substantially equivalent to K032401 (Omsbar, Ltd., 2003) and 1 other predicate after an 85-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it.
- Decided
- Jul 27, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K896095 (1990). 7 ancestors in all. 2 later devices descend from it, 1 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 deviceK041162 Ortho-CMSMedis Medical Imaging Systems BV · 2004
- Descendant · cites it directly · 1 of its ownK042383 Rsa-CMSMedis Medical Imaging Systems BV · 2004
- Descendant · 2 generations on · 0 of its ownK133966 Model-Based Rsa SoftwareHalifax Biomedical, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView 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) | K041162 | Ortho-CMS | Medis Medical Imaging Systems BV | 2004 | — |
| +1 | K042383 | Rsa-CMS | Medis Medical Imaging Systems BV | 2004 | — |
| +2 | K133966 | Model-Based Rsa Software | Halifax Biomedical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2014 | 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? (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 1…: System Image Processing, Radiological Regulation Number : 21 CFR 892.2050 (90 LLZ; Class II) 3. Predicate Device(s) Meridian Technique Ltd: 510(k) K032401 eFilm Medical Inc.: 510(k) K020995 4. Description of the device: In orthopaedics, radiographs are… | 2003 |
| * | K020995 | Efilm Workstation with ModulesSummary page 1…: 21 CFR 892.2050 (90 LLZ; Class II) 3. Predicate Device(s) Meridian Technique Ltd: 510(k) K032401 eFilm Medical Inc.: 510(k) K020995 4. Description of the device: In orthopaedics, radiographs are used to diagnose and analyse various kinds of orthopaedic disorde… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042383 | Rsa-CMS | 2004 | 1 |
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 7 ancestors have a recall of any class.
- Of its descendants, K042383 (Medis Medical Imaging Systems BV, 2004) has gone furthest, with 1 descendant 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?
Ortho-CMS is an orthopaedic analysis software tool. It has been developed to optimize preoperative planning through digital prosthesis templating and to enable preoperative and postoperative measurements in digital or digitized X-Ray images. Ortho-CMS software is meant solely for use by trained medical personnel.
The intended purposes of Ortho-CMS are:
Displaying of X-Ray images
Supporting planning of joint replacement operations
Supporting clinical diagnoses on implant loosening
Enabling preoperative and postoperative measurements for clinical and research purposes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041162: Ortho-CMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041162
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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