510(k) · Cleared
ClearedFX SPS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pixee Medical · LLZ System, Image Processing, Radiological
Cleared on Jul 22, 2022 as substantially equivalent to K201928 (FH Industrie, 2020) after a 219-day review. Its family tree reaches back 11 generations to 1990. 2 later devices descend from it.
- Decided
- Jul 22, 2022
- Review
- 219 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. 2 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 backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- 2 generations backK160284 JointPointJointpoint, Inc. · 2016
- 1 generation backK201928 e-Ortho Shoulder SoftwareFH Industrie · 2020
- This deviceK213922 FX SPSPixee Medical · 2022
- Descendant · cites it directly · 0 of its ownK252665 brAIn™ Shoulder PositioningAvatar Medical · 2025
- Descendant · cites it directly · 0 of its ownK243292 brAIn™ Shoulder PositioningAvatar Medical · 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 backK201928 e-Ortho Shoulder SoftwareFH Industrie · 2020
- This deviceK213922 FX SPSPixee Medical · 2022
Most influential descendants
Showing 2 of 2 · 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 | K201928 | e-Ortho Shoulder Software | FH Industrie | 2020 | — |
| 0 (this device) | K213922 | FX SPS | Pixee Medical | 2022 | — |
| +1 | K252665 | brAIn™ Shoulder Positioning | Avatar Medical | 2025 | — |
| +1 | K243292 | brAIn™ Shoulder Positioning | Avatar Medical | 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 | 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 21.6 · 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 |
|---|---|---|---|
| * | K201928 | e-Ortho Shoulder SoftwareSummary page 4…t Name Device Name Product code 510(k) number FH INDUSTRIE e-Ortho Shoulder Software LLZ K201928 No reference devices were used in this submission. Device Description: FX SPS is a preoperative standalone web-based medical… | 2020 |
What descends from it? (2)
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 9 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, K252665 (Avatar Medical, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K201928.
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?
FX SPS is intended to be used as an information tool to assist in the preoperative surgical planning and
visualization of a primary total shoulder replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213922 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213922: FX SPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213922
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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