510(k) · Cleared
ClearedMySpine WebPlanner
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 Apr 23, 2025 as substantially equivalent to K211386 (Medacta International S.A., 2021) after a 145-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Apr 23, 2025
- Review
- 145 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K896095 (1990). 23 ancestors in all. No later device cites it as a predicate yet.
- 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 backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- 1 generation backK211386 MySpine WebPlanner & MyBalanceMedacta International S.A. · 2021
- This deviceK243697 MySpine WebPlannerMedacta International S.A. · 2025
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 backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- 1 generation backK211386 MySpine WebPlanner & MyBalanceMedacta International S.A. · 2021
- This deviceK243697 MySpine WebPlannerMedacta International S.A. · 2025
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 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| −1 | K211386 | MySpine WebPlanner & MyBalance | Medacta International S.A. | 2021 | — |
| 0 (this device) | K243697 | MySpine WebPlanner | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K211386 | MySpine WebPlanner & MyBalanceSummary page 5…mary Product Code: LLZ Regulation Number: 21 CFR 892.2050 Device Classification: II III. Predicate Device MySpine WebPlanner & MyBalance, K211386, Medacta International SA IV. Device Description The MySpine WebPlanner is an interactive web application using the patient’… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 7 companies; a new generation was cleared every 3.4 years on median.
- 5 of the 23 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. The MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta’s…
Read the full statement (113 words)
The MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. The MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta’s spinal fixation and fusion devices in skeletally mature and immature individuals. The MySpine WebPlanner software is designed to support the surgeon in producing a preoperative plan and making preliminary decisions on implant size and positioning. To properly use the MySpine WebPlanner, clinical judgment, and experience are required.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243697 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243697: MySpine WebPlanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243697
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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