510(k) · Cleared
ClearedKneekg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emovi · LXJ Interactive Rehabilitation Exercise Devices
Cleared on Oct 26, 2009 as substantially equivalent to K033514 (Charnwood Dynamics, Ltd., 2004) and 1 other predicate after a 201-day review. Its family tree reaches back 3 generations to 1989. 1 of the 11 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 26, 2009
- Review
- 201 days
- Class
- Class II
- Product code
- LXJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K890076 (1989). 10 ancestors in all. No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK890076 OrthotrakMotion Analysis Corp. · 1989
- 2 generations backK982425 Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering · 1998
- 1 generation backK033514 Coda CX1 Motion Analysis SystemCharnwood Dynamics, Ltd. · 2004
- This deviceK091000 KneekgEmovi · 2009
Class I recalls in this family
- K040050 Instatrak System with Multiple Dataset…direct predicate · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890076 | Orthotrak | Motion Analysis Corp. | 1989 | — |
| −2 | K982425 | Coda MPX30 Motion Analysis System | Pinsco Inc. Dba B & L Engineering | 1998 | — |
| −1 | K033514 | Coda CX1 Motion Analysis System | Charnwood Dynamics, Ltd. | 2004 | — |
| 0 (this device) | K091000 | Kneekg | Emovi | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 1 |
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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K033514 | Coda CX1 Motion Analysis SystemSummary page 1…Date Summary Prepared: March 27, 2009 5. Device Name: KneeKG 6. Predicates Devices: Code CX1 Motion Analysis System (K033514) InstaTrak with Multiple dataset Navigation (K040050) 7. Device Description: T… | 2004 |
| * | K040050 | Instatrak System with Multiple Dataset Navigation, Model IT3500Summary page 1…eKG 6. Predicates Devices: Code CX1 Motion Analysis System (K033514) InstaTrak with Multiple dataset Navigation (K040050) 7. Device Description: The KneeKG measures and analyzes the 3D position and movement of electromagnetic markers… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K033514.
How does its category compare?
All LXJ devicesLXJ Interactive Rehabilitation Exercise Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LXJ
3in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LXJ
224in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LXJ
No recall names LXJ since 2007.
Adverse event reports per year · LXJ
1in 2018
MAUDE reports naming product code LXJ, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 182 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 231 | 0 | 1 |
| 2019 | 3 | 224 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Measure and analyze 3D position and movement by placing markers on the knees of patients whose movement function is to be assessed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091000: Kneekg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091000
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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