510(k) · Cleared
ClearedBonelogic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disior, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Feb 5, 2021 as substantially equivalent to K183105 (Materialise NV, 2019) after an 88-day review. Its family tree reaches back 5 generations to 1993. 5 later devices descend from it.
- Decided
- Feb 5, 2021
- Review
- 88 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924630 (1993). 6 ancestors in all, the oldest K924810 (1993). 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 4 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 3 generations backK033849 Simplant SystemMaterialise NV · 2004
- 2 generations backK073468 MimicsMaterialise NV · 2008
- 1 generation backK183105 Mimics MedicalMaterialise NV · 2019
- This deviceK203290 BonelogicDisior, Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK223757 BonelogicDisior, Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK240642 SMART Bun-Yo-Matic CTDisior, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK261641 Lower Limb AI (LLAI)AI Planning Logic, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250023 Smart PCFDDisior, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK240736 SMART Bun-Yo-Matic X-RayDisior, Ltd. · 2024
Most influential descendants
Showing 5 of 5 · See all- K223757BonelogicDisior, Ltd. · 2023 · cites it directly4descendants
- K240642SMART Bun-Yo-Matic CTDisior, Ltd. · 2024 · 2 generations on2descendants
- K261641Lower Limb AI (LLAI)AI Planning Logic, Inc. · 2026 · 3 generations on0descendants
- K250023Smart PCFDDisior, Ltd. · 2025 · 2 generations on0descendants
- K240736SMART Bun-Yo-Matic X-RayDisior, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −4 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −3 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −2 | K073468 | Mimics | Materialise NV | 2008 | — |
| −1 | K183105 | Mimics Medical | Materialise NV | 2019 | — |
| 0 (this device) | K203290 | Bonelogic | Disior, Ltd. | 2021 | — |
| +1 | K223757 | Bonelogic | Disior, Ltd. | 2023 | — |
| +2 | K240642 | SMART Bun-Yo-Matic CT | Disior, Ltd. | 2024 | — |
| +3 | K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | 2026 | — |
| +2 | K250023 | Smart PCFD | Disior, Ltd. | 2025 | — |
| +2 | K240736 | SMART Bun-Yo-Matic X-Ray | Disior, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K183105 | Mimics MedicalSummary page 4…duct Code: LLZ (892.2050) Predicate device The primary predicate device to which substantial equivalence is claimed: 510(K) No. K183105 Clearance Date: March 27, 2019 Device Name: Mimics Medical Manufacturer:… | 2019 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223757 | Bonelogic | 2023 | 4 |
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 28 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K223757 (Disior, Ltd., 2023) has gone furthest, with 4 descendants of its own.
- 16 other devices also cite its predicate K183105.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Bonelogic software is intended to be used by specialized medical practitioners to assist in the characterization of human anatomy with 3D visualization and specific measurements. The medical image modalities intended to be used in the software are computed tomography (CT) images, cone beam computed tomography (CBCT) images and weight-bearing cone beam CT (WBCT) images. The intended patient population is adults over 16 years of age. Bonelogic software…
Read the full statement (159 words)
Bonelogic software is intended to be used by specialized medical practitioners to assist in the characterization of human anatomy with 3D visualization and specific measurements. The medical image modalities intended to be used in the software are computed tomography (CT) images, cone beam computed tomography (CBCT) images and weight-bearing cone beam CT (WBCT) images. The intended patient population is adults over 16 years of age.
Bonelogic software contains the measurement template with a set of distance and angular measures. The measurements can be used for diagnostic purposes. The three dimensional (3D) models are displayed and can be manipulated in the software. Together, the information from the measurements and the 3D visualization can be used for treatment planning in the field of orthopedics (foot and ankle, and hand and wrist). The 3D models can be outputted from the software for traditional or additive manufacturing. The physical models generated based on the 3D digital models are not intended for diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203290: Bonelogic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203290
Report an extraction error
Are you the manufacturer?
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