510(k) Report

510(k) · Cleared

Cleared

Orthotrak

K890076510(k) TraditionalCleared Feb 3, 198925-day reviewClass II21 CFR 890.5360

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Motion Analysis Corp. · LXJ Interactive Rehabilitation Exercise Devices

Cleared on Feb 3, 1989 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.

Decided
Feb 3, 1989
Review
25 days
Class
Class II
Product code
LXJ
Recalls
None
Predicates
0

14 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2004: 1 descendant cleared2003: 1 descendant cleared2014: 2 descendants cleared2015: 3 descendants cleared2019: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2016: 1 descendant cleared2018: 2 descendants cleared1990200020102020
  1. This deviceK890076 OrthotrakMotion Analysis Corp. · 1989
  2. Descendant · cites it directly · 13 of its ownK982425 Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering · 1998
  3. Descendant · 2 generations on · 10 of its ownK033514 Coda CX1 Motion Analysis SystemCharnwood Dynamics, Ltd. · 2004
  4. Descendant · 2 generations on · 10 of its ownK030714 Peak MotusPeak Performance Technologies, Inc. · 2003
  5. Descendant · 3 generations on · 6 of its ownK130847 Jintronix Rehabilitation System (JRS)Jintronix, Inc. · 2014
  6. Descendant · 4 generations on · 1 of its ownK151446 Recovr Rehabilitation SystemRecovr,Inc · 2015

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

1998: 12003: 12004: 12009: 12014: 22015: 32016: 12017: 12018: 22019: 1
1998high 3 (2015) · low 0 (1999)2026

Most influential descendants

Showing 5 of 14 · See all
  • K982425Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering · 1998 · cites it directly13descendants
  • K033514Coda CX1 Motion Analysis SystemCharnwood Dynamics, Ltd. · 2004 · 2 generations on10descendants
  • K030714Peak MotusPeak Performance Technologies, Inc. · 2003 · 2 generations on10descendants
  • K130847Jintronix Rehabilitation System (JRS)Jintronix, Inc. · 2014 · 3 generations on6descendants
  • K151446Recovr Rehabilitation SystemRecovr,Inc · 2015 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K890076OrthotrakMotion Analysis Corp.1989—
+1K982425Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering1998—
+2K033514Coda CX1 Motion Analysis SystemCharnwood Dynamics, Ltd.2004—
+2K030714Peak MotusPeak Performance Technologies, Inc.2003—
+3K130847Jintronix Rehabilitation System (JRS)Jintronix, Inc.2014—
+4K151446Recovr Rehabilitation SystemRecovr,Inc2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200310
200410
200910
201420
201530
201610
201710
201820
201910
FIG. 1 — Lineage of K890076, 1989–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LXJ? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982425Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering199813

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?

  • Of its descendants, K982425 (Pinsco Inc. Dba B & L Engineering, 1998) has gone furthest, with 13 descendants of its own.

How does its category compare?

All LXJ devices

LXJ Interactive Rehabilitation Exercise Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXJ

3in 2019

2009: 12014: 22015: 32016: 12017: 22018: 32019: 3
2007high 3 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXJ

224in 2019

2015: 182 days median2018: 231 days median2019: 224 days median
2007high 231 (2018) · low 182 (2015)2026

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

2018: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code LXJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20120—00
20130—00
20142—00
2015318200
20161—00
20172—00
2018323101
2019322400
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K890076: Orthotrak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K890076

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026