510(k) · Cleared
ClearedCUPTIMIZE™ Advanced
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 22, 2023 as substantially equivalent to K203651 (Cuptimize, Inc., 2021) after a 90-day review. Its family tree reaches back 11 generations to 1990. 1 later device descends from it.
- Decided
- Aug 22, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K896095 (1990). 26 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations between
- 3 generations backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- 2 generations backK160284 JointPointJointpoint, Inc. · 2016
- 1 generation backK203651 CuptimizeCuptimize, Inc. · 2021
- This deviceK231503 CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
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 backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- 2 generations backK160284 JointPointJointpoint, Inc. · 2016
- 1 generation backK203651 CuptimizeCuptimize, Inc. · 2021
- This deviceK231503 CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K242161Radlink GPS Pro ImagingRadlink, Inc. · 2025 · 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 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| −2 | K160284 | JointPoint | Jointpoint, Inc. | 2016 | — |
| −1 | K203651 | Cuptimize | Cuptimize, Inc. | 2021 | — |
| 0 (this device) | K231503 | CUPTIMIZE™ Advanced | DePuy Orthopaedics, Inc. | 2023 | — |
| +1 | K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K203651 | CuptimizeSummary page 4…mber 892.2050 Product Code LLZ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K203651 Cuptimize L Device Description Summary 21 CFR 807.92(a)(4) CUPTIMIZE™ Advanced is a software as a medical device (SaMD) system t… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242161 | Radlink GPS Pro Imaging | 2025 | 0 |
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 33 years and passes through 9 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K242161 (Radlink, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K203651.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
CUPTIMIZE™ Advanced is an image-processing software indicated to assist in the positioning of total hip replacement components, with a specific focus on the acetabular component. It is intended to assist in the precise positioning of the acetabular component intra-operatively by measuring its position relative to the bone structures of interest provided that the points of interest can be identified from radiology images. The device allows for overlaying…
Read the full statement (113 words)
CUPTIMIZE™ Advanced is an image-processing software indicated to assist in the positioning of total hip replacement components, with a specific focus on the acetabular component.
It is intended to assist in the precise positioning of the acetabular component intra-operatively by measuring its position relative to the bone structures of interest provided that the points of interest can be identified from radiology images.
The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
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/K231503 · printed Nov 4, 2026
Cite this page
510(k) Report. “K231503: CUPTIMIZE™ Advanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K231503
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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