510(k) · Cleared
ClearedKnee+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pixee Medical · SBF Orthopedic Augmented Reality
Cleared on Sep 1, 2022 as substantially equivalent to K202750 (Pixee Medical, 2021) after a 232-day review. Its family tree reaches back 6 generations to 2000. 2 of the 21 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Sep 1, 2022
- Review
- 232 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002053 (2000). 13 ancestors in all, the oldest K992927 (1999). 7 later devices descend from it, 2 citing it directly. 2 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 5 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 4 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 3 generations backK060336 Navitrack System-OS Knee Universal, Model Pro-05002Orthosoft, Inc. · 2006 · Recalled
- 2 generations backK110054 Navitrack System - OS Knee Universal, Cas Same Incision Tibia…Zimmer Cas · 2011 · Recalled
- 1 generation backK202750 Knee+Pixee Medical · 2021
- This deviceK220104 Knee+Pixee Medical · 2022
- Descendant · cites it directly · 5 of its ownK230789 Knee+Pixee Medical · 2023
- Descendant · 2 generations on · 4 of its ownK233899 Knee+Pixee Medical · 2024
- Descendant · 3 generations on · 3 of its ownK243975 Knee+Pixee Medical · 2025
- Descendant · 4 generations on · 1 of its ownK250108 OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025
- Descendant · 4 generations on · 0 of its ownK253805 Knee+Pixee Medical S.A.S. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K230789Knee+Pixee Medical · 2023 · cites it directly5descendants
- K233899Knee+Pixee Medical · 2024 · 2 generations on4descendants
- K243975Knee+Pixee Medical · 2025 · 3 generations on3descendants
- K250108OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025 · 4 generations on1descendant
- K253805Knee+Pixee Medical S.A.S. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −5 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −4 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −3 | K060336 | Navitrack System-OS Knee Universal, Model Pro-05002 | Orthosoft, Inc. | 2006 | 3 |
| −2 | K110054 | Navitrack System - OS Knee Universal, Cas Same Incision Tibia Reference | Zimmer Cas | 2011 | 2 |
| −1 | K202750 | Knee+ | Pixee Medical | 2021 | — |
| 0 (this device) | K220104 | Knee+ | Pixee Medical | 2022 | — |
| +1 | K230789 | Knee+ | Pixee Medical | 2023 | — |
| +2 | K233899 | Knee+ | Pixee Medical | 2024 | — |
| +3 | K243975 | Knee+ | Pixee Medical | 2025 | — |
| +4 | K250108 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K202750 | Knee+Summary page 4…Name Device Name Product code 510(k) number Pixee Medical Knee+ OLO K202750 No reference devices were used in this submission. Device Description: The main purpose of Knee+ is to assist the surgeon dur… | 2021 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 13 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K230789 (Pixee Medical, 2023) has gone furthest, with 5 descendants of its own.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 as stated in the FDA summary.
https://510kreport.com/device/K220104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220104: Knee+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220104
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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