510(k) · Cleared
ClearedOnefit Hip Planner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onefit Medical · LLZ System, Image Processing, Radiological
Cleared on Dec 5, 2014 as substantially equivalent to K073714 (Orthocrat, Ltd., 2008) after a 77-day review. Its family tree reaches back 8 generations to 1990. 10 later devices descend from it.
- Decided
- Dec 5, 2014
- Review
- 77 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 21 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 2 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 1 generation backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- This deviceK142671 Onefit Hip PlannerOnefit Medical · 2014
- Descendant · cites it directly · 9 of its ownK161479 hipEOSOnefit Medical · 2016
- Descendant · 2 generations on · 8 of its ownK173390 hipEOSOnefit Medical · 2018
- Descendant · 3 generations on · 3 of its ownK212040 RI.Hip ModelerBlue Belt Technologies, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
- Descendant · 4 generations on · 1 of its ownK242272 CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K161479hipEOSOnefit Medical · 2016 · cites it directly9descendants
- K173390hipEOSOnefit Medical · 2018 · 2 generations on8descendants
- K212040RI.Hip ModelerBlue Belt Technologies, Inc. · 2022 · 3 generations on3descendants
- K192656Optimized Positioning System (OPS) InsightCorin USA · 2020 · 3 generations on3descendants
- K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −2 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −1 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| 0 (this device) | K142671 | Onefit Hip Planner | Onefit Medical | 2014 | — |
| +1 | K161479 | hipEOS | Onefit Medical | 2016 | — |
| +2 | K173390 | hipEOS | Onefit Medical | 2018 | — |
| +3 | K212040 | RI.Hip Modeler | Blue Belt Technologies, Inc. | 2022 | — |
| +3 | K192656 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | — |
| +4 | K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K073714 | Traumacad Version 2.0Summary page 4…stem Classification Name: Picture Archiving and Communication System (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ Predicate Devices TraumaCAD Release 2.0 (K073714) by Orthocrat, Ltd. Intended Use/Indications for Use The ONEFIT Hip Planner software is indicated for assisting healthcare profe… | 2008 |
| † | K071546 | EOS | 2007 |
| † | K141137 | Stereos Workstation | 2014 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161479 | hipEOS | 2016 | 9 |
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 24 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K161479 (Onefit Medical, 2016) has gone furthest, with 9 descendants of its own.
- 12 other devices also cite its predicate K073714.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ONEFIT Hip Planner software is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and 3D model of bones and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.
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/K142671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142671: Onefit Hip Planner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142671
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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