510(k) · Cleared
ClearedRI.Hip Modeler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Belt Technologies, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 11, 2022 as substantially equivalent to K173390 (Onefit Medical, 2018) after a 254-day review. Its family tree reaches back 11 generations to 1990. 3 later devices descend from it.
- Decided
- Mar 11, 2022
- Review
- 254 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K896095 (1990). 30 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations between
- 3 generations backK142671 Onefit Hip PlannerOnefit Medical · 2014
- 2 generations backK161479 hipEOSOnefit Medical · 2016
- 1 generation backK173390 hipEOSOnefit Medical · 2018
- This deviceK212040 RI.Hip ModelerBlue Belt Technologies, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK242272 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK250921 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243447 Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 10 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 9 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 8 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 7 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 6 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 5 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 4 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 3 generations backK142671 Onefit Hip PlannerOnefit Medical · 2014
- 2 generations backK161479 hipEOSOnefit Medical · 2016
- 1 generation backK173390 hipEOSOnefit Medical · 2018
- This deviceK212040 RI.Hip ModelerBlue Belt Technologies, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024 · cites it directly1descendant
- K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2025 · 2 generations on0descendants
- K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −10 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −9 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −8 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −7 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −6 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −5 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −4 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −3 | K142671 | Onefit Hip Planner | Onefit Medical | 2014 | — |
| −2 | K161479 | hipEOS | Onefit Medical | 2016 | — |
| −1 | K173390 | hipEOS | Onefit Medical | 2018 | — |
| 0 (this device) | K212040 | RI.Hip Modeler | Blue Belt Technologies, Inc. | 2022 | — |
| +1 | K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2024 | — |
| +2 | K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025 | — |
| +1 | K243447 | Rapid Surgical Plan (RSP-SW-001) | Navbit Pty, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K173390 | hipEOSSummary page 4…ng and communications system Trade/Proprietary Name RI.HIP MODELER™ Predicate Device(s) OneFit Medical - hipEOS (K173390) Reason for Submission New Device Indications for Use RI.HIP MODELER is intended for preopera… | 2018 |
What descends from it? (3)
2 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 32 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 30 ancestors have a recall of any class.
- Of its descendants, K242272 (Blue Belt Technologies, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K173390.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
RI.LHIP MODELER is intended for preoperative planning for primary total hip arthroplasty. R.LHIP MODELER is intended to be used as a tool to assist the surgeon in the selection and positioning of components in primary total hip arthroplasty.
RI.HIP MODELER is indicated for individuals undergoing primary hip surgery.
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/K212040 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212040: RI.Hip Modeler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212040
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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