510(k) · Cleared
ClearedMyHip Planner & Verifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · LLZ System, Image Processing, Radiological
Cleared on Nov 4, 2020 as substantially equivalent to K170702 (Medicad Hectec GmbH, 2018) and 1 other predicate after a 266-day review. Its family tree reaches back 10 generations to 1990. 1 later device descends from it.
- Decided
- Nov 4, 2020
- Review
- 266 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K896095 (1990). 26 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations between
- 3 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 2 generations backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- 1 generation backK160284 JointPointJointpoint, Inc. · 2016
- This deviceK200350 MyHip Planner & VerifierMedacta International S.A. · 2020
- Descendant · cites it directly · 0 of its ownK221725 Advanced MyHip PlannerMedacta International S.A. · 2023
Show all 10 generations
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 8 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 7 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 6 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 5 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 4 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 3 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 2 generations backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- 1 generation backK160284 JointPointJointpoint, Inc. · 2016
- This deviceK200350 MyHip Planner & VerifierMedacta International S.A. · 2020
Most influential descendants
Showing 1 of 1 · See all- K221725Advanced MyHip PlannerMedacta International S.A. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −9 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −8 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −7 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −6 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −5 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −4 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −3 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −2 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| −1 | K160284 | JointPoint | Jointpoint, Inc. | 2016 | — |
| 0 (this device) | K200350 | MyHip Planner & Verifier | Medacta International S.A. | 2020 | — |
| +1 | K221725 | Advanced MyHip Planner | Medacta International S.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K170702 | mediCAD 4.0Summary page 4…ation II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device for MyHip Planner: x MediCAD 4.0, K170702, MediCAD Hectec Gmbh Primary predicate device for MyHip Verifier: x JointPoint, K160284, JointPoint Inc. IV. Device De… | 2018 |
| * | K160284 | JointPointSummary page 4…g devices: Primary predicate device for MyHip Planner: x MediCAD 4.0, K170702, MediCAD Hectec Gmbh Primary predicate device for MyHip Verifier: x JointPoint, K160284, JointPoint Inc. IV. Device Description The MyHip Planner is a software whose output is a patient-specific preoperative pl… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221725 | Advanced MyHip Planner | 2023 | 0 |
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 30 years and passes through 8 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K221725 (Medacta International S.A., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 MyHip Planner software is intended for image processing and pre-operative planning of acetabular cup and femoral stem positioning for Total Hip Arthroplasty (THA). The device assists the user in assessing potential leg length and offset differences as well as potential range of motion impingement.
The MyHip Verifier software is intended to assist in the intra-operative evaluation of leg length and offset differences as well as acetabular cup positioning for anterior approach Total Hip Arthroplasty when the patient is positioned supine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200350 · printed Nov 5, 2026
Cite this page
510(k) Report. “K200350: MyHip Planner & Verifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K200350
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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