510(k) · Cleared
ClearedmediCAD 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicad Hectec GmbH · LLZ System, Image Processing, Radiological
Cleared on Sep 7, 2018 after a 548-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Sep 7, 2018
- Review
- 548 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
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 |
|---|---|---|---|---|---|
| 0 (this device) | K170702 | mediCAD 4.0 | Medicad Hectec GmbH | 2018 | — |
| +1 | K200350 | MyHip Planner & Verifier | Medacta International S.A. | 2020 | — |
| +2 | K221725 | Advanced MyHip Planner | Medacta International S.A. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K200350 | MyHip Planner & Verifier | 2020 | 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?
- Of its descendants, K200350 (Medacta International S.A., 2020) has gone furthest, with 1 descendant 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. 2018, 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 mediCAD classic V4.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS-systems or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD classic 4.0 can…
Read the full statement (286 words)
The mediCAD classic V4.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays (2D) and CT (3D). The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS-systems or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD classic 4.0 can hand over the digital plannings as DICOMs to PACS-systems. Federal law restricts this device to sale by or on the order of a health professional.
mediCAD will also support the proper workflow necessary to effectively compare pre- and post-operative radiograph studies for a unique understanding of the patient’s surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient’s relevant treatment and therapy.
The system is designed for the following medical specialties:
• Orthopedics
• Surgery and Traumatology
• Rheumatology
• Pediatric Orthopedics
MediCAD is designed for pre-operative planning for the following applications:
• Hip - Manual Planning
• Hip - Automatic Planning
• Hip - Biometry
• Hip – Intertrochanteric osteotomy
• Hip - Coxometry
• Hip - Wear Measurement
• Hip - FAI
• Knee Prosthetic Planning
• Biometry Planning –takes into account patient motion and metrics
•Coxometry – tracking of known measurement values in pediatrics to determine surgical intervention
• Osteotomy – determines optimum osteotomy locations
• Osteotomy by Dror Paley
• Osteotomy (DualSide)
• Spine
• Foot – Hallux Valgus
• Foot – Ankle Joint
• Upper Extremities
• Biological Age Determination by Hand
• Trauma
• Hip 3D
• Spine 3D
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K170702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170702: mediCAD 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170702
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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