510(k) · Cleared
ClearedKnee+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pixee Medical S.A.S. · SBF Orthopedic Augmented Reality
Cleared on Apr 24, 2026 as substantially equivalent to K243975 (Pixee Medical, 2025) after a 147-day review. Its family tree reaches back 10 generations to 2000. 2 of the 18 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 24, 2026
- Review
- 147 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K002053 (2000). 17 ancestors in all, the oldest K992927 (1999). No later device cites it as a predicate yet. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 6 generations between
- 3 generations backK230789 Knee+Pixee Medical · 2023
- 2 generations backK233899 Knee+Pixee Medical · 2024
- 1 generation backK243975 Knee+Pixee Medical · 2025
- This deviceK253805 Knee+Pixee Medical S.A.S. · 2026
Show all 10 generations
- Root · 10 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 9 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 8 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 7 generations backK060336 Navitrack System-OS Knee Universal, Model Pro-05002Orthosoft, Inc. · 2006 · Recalled
- 6 generations backK110054 Navitrack System - OS Knee Universal, Cas Same Incision Tibia…Zimmer Cas · 2011 · Recalled
- 5 generations backK202750 Knee+Pixee Medical · 2021
- 4 generations backK220104 Knee+Pixee Medical · 2022
- 3 generations backK230789 Knee+Pixee Medical · 2023
- 2 generations backK233899 Knee+Pixee Medical · 2024
- 1 generation backK243975 Knee+Pixee Medical · 2025
- This deviceK253805 Knee+Pixee Medical S.A.S. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −9 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −8 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −7 | K060336 | Navitrack System-OS Knee Universal, Model Pro-05002 | Orthosoft, Inc. | 2006 | 3 |
| −6 | K110054 | Navitrack System - OS Knee Universal, Cas Same Incision Tibia Reference | Zimmer Cas | 2011 | 2 |
| −5 | K202750 | Knee+ | Pixee Medical | 2021 | — |
| −4 | K220104 | Knee+ | Pixee Medical | 2022 | — |
| −3 | K230789 | Knee+ | Pixee Medical | 2023 | — |
| −2 | K233899 | Knee+ | Pixee Medical | 2024 | — |
| −1 | K243975 | Knee+ | Pixee Medical | 2025 | — |
| 0 (this device) | K253805 | Knee+ | Pixee Medical S.A.S. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2019 | 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.
2 devices in this family have a Class I recall. 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 SBF device
- #1 K193559 NextAR TKA Platformscore 20.3 · 10 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 |
|---|---|---|---|
| * | K243975 | Knee+Summary page 5…Applicant Name Device Name Product code 510(k) Number Pixee Medical Knee+ SBF K243975 No reference devices were used in this submission. Device Description: The main purpose of Knee+ is to assist the surgeon d… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 6 of the 17 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K243975.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SBF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SBF
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SBF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · SBF
1in 2025
MAUDE reports naming product code SBF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 4 | 162 | 0 | 0 |
| 2022 | 7 | 234 | 0 | 0 |
| 2023 | 7 | 104 | 0 | 0 |
| 2024 | 6 | 89 | 0 | 0 |
| 2025 | 13 | 90 | 1 | 1 |
| 2026 | 3 | 123 | 1 | — |
What is it indicated for?
Knee+ is a stereotaxic system including an intraoperative software as a medical device and surgical instruments.
Knee+ is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting guide regarding computed mechanical axis. The Knee+ includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.
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/K253805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253805: Knee+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253805
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026