510(k) · Cleared
ClearedPhantomMSK Hip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OrthoGrid Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 18, 2021 as substantially equivalent to K182332 (OrthoGrid Systems, Inc., 2019) after a 30-day review. Its family tree reaches back 11 generations to 1990. 3 later devices descend from it.
- Decided
- Feb 18, 2021
- Review
- 30 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. 3 later devices descend from it, 3 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 backK182332 PhantomMSKOrthoGrid Systems, Inc. · 2019
- This deviceK210136 PhantomMSK HipOrthoGrid Systems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK260077 OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260321 HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC · 2026
- Descendant · cites it directly · 0 of its ownK252214 AIAS CephalonMetamorphosis GmbH · 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 backK182332 PhantomMSKOrthoGrid Systems, Inc. · 2019
- This deviceK210136 PhantomMSK HipOrthoGrid Systems, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See allView 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 | K182332 | PhantomMSK | OrthoGrid Systems, Inc. | 2019 | — |
| 0 (this device) | K210136 | PhantomMSK Hip | OrthoGrid Systems, Inc. | 2021 | — |
| +1 | K260077 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | 2026 | — |
| +1 | K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026 | — |
| +1 | K252214 | AIAS Cephalon | Metamorphosis GmbH | 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 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K182332 | PhantomMSKSummary page 4…tion Name: Picture Archiving and Communications System (21 CFR 892.2050) Regulatory Class: Class II Product Code: LLZ Predicate Devices: PhantomMSK (K182332) Device Description: The PhantomMSK Hip is a non-invasive software system that provides image analysis tools for Total Hip Repl… | 2019 |
What descends from it? (3)
3 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 31 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K260077 (OrthoGrid Systems, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K182332.
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?
PhantomMSK Hip is an image-processing software indicated to assist in the positioning of Total Hip Replacement and Hip Preservation components. It is intended to assist in precisely positioning Total Hip Replacement and Hip Preservation components intraoperatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images. Clinical judgement and experience are required to properly use the device. The device 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/K210136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210136: PhantomMSK Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210136
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