510(k) · Cleared
ClearedOrthoview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merdian Technique, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Nov 22, 2006 as substantially equivalent to K042816 (Orthocrat, Ltd., 2004) and 1 other predicate after a 19-day review. Its family tree reaches back 7 generations to 1990. 13 later devices descend from it.
- Decided
- Nov 22, 2006
- Review
- 19 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K896095 (1990). 10 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 3 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 2 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 1 generation backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- This deviceK063327 OrthoviewMerdian Technique, Ltd. · 2006
- Descendant · cites it directly · 10 of its ownK133022 ZedviewLexi Co., Ltd. · 2014
- Descendant · 2 generations on · 6 of its ownK171847 Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited · 2018
- Descendant · 3 generations on · 5 of its ownK183038 Corin Optimized Positioning System (OPS) PlanCorin USA · 2018
- Descendant · 3 generations on · 3 of its ownK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
- Descendant · 2 generations on · 0 of its ownK211429 NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K133022ZedviewLexi Co., Ltd. · 2014 · cites it directly10descendants
- K171847Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited · 2018 · 2 generations on6descendants
- K183038Corin Optimized Positioning System (OPS) PlanCorin USA · 2018 · 3 generations on5descendants
- K192656Optimized Positioning System (OPS) InsightCorin USA · 2020 · 3 generations on3descendants
- K211429NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −3 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −2 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −1 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| 0 (this device) | K063327 | Orthoview | Merdian Technique, Ltd. | 2006 | — |
| +1 | K133022 | Zedview | Lexi Co., Ltd. | 2014 | — |
| +2 | K171847 | Corin Optimized Positioning System (OPS™) Plan | Corin U.S.A. Limited | 2018 | — |
| +3 | K183038 | Corin Optimized Positioning System (OPS) Plan | Corin USA | 2018 | — |
| +3 | K192656 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | — |
| +2 | K211429 | NAVIPLAN - CT Planning Software for Total Hip Replacement | Naviswiss AG | 2021 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 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 |
|---|---|---|---|
| * | K042816 | Traumacad 1.2Summary page 1…ACS) System Common Name PACS System Proprietary Name OrthoVieWTM Predicate Device 5 10k references K042816 and K032401 Substantial equivalence is claimed between OrthovieWT-M and Manufacturer Orthoerat Ltd 'fradename… | 2004 |
| * | K032401 | OrthoviewSummary page 1…Common Name PACS System Proprietary Name OrthoVieWTM Predicate Device 5 10k references K042816 and K032401 Substantial equivalence is claimed between OrthovieWT-M and Manufacturer Orthoerat Ltd 'fradename TraumnaCAD… | 2003 |
What descends from it? (13)
See all 133 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 16 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K133022 (Lexi Co., Ltd., 2014) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K042816.
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?
OrthoviewTM is indicated for use when a suitably licensed and qualified healthcare professional requires access to medical images with the intention of using such images, in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the nature and characteristics of the prosthetic/fixation device to be used when planning a potential surgical procedure. In addition, Trauma and Osteotomy modules and Trauma Templates are provided to extend the range of functionality available to the healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063327 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063327: Orthoview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063327
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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