510(k) · Cleared
ClearedOrthocor Knee System, Median, Large, X-Large
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocor Medical · ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Cleared on Dec 18, 2009 as substantially equivalent to K070541 (Ivivi Technologies, Inc., 2008) after a 165-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Dec 18, 2009
- Review
- 165 days
- Class
- Class II
- Product code
- ILX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K903675 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK903675 Magnetic Resonance Therapy DeviceMrt, Inc. · 1991
- 1 generation backK070541 Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIIvivi Technologies, Inc. · 2008
- This deviceK092044 Orthocor Knee System, Median, Large, X-LargeOrthocor Medical · 2009
- Descendant · cites it directly · 1 of its ownK152432 ActiPatch (R)Bioelectronics Corporation · 2017
- Descendant · cites it directly · 0 of its ownK241395 Active System; Avenue8Caerus Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK192234 ActiPatchBioelectronics Corporation · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903675 | Magnetic Resonance Therapy Device | Mrt, Inc. | 1991 | — |
| −1 | K070541 | Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II | Ivivi Technologies, Inc. | 2008 | — |
| 0 (this device) | K092044 | Orthocor Knee System, Median, Large, X-Large | Orthocor Medical | 2009 | — |
| +1 | K152432 | ActiPatch (R) | Bioelectronics Corporation | 2017 | — |
| +1 | K241395 | Active System; Avenue8 | Caerus Corporation | 2024 | — |
| +2 | K192234 | ActiPatch | Bioelectronics Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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.
Planning a device in ILX? 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 ILX device
- #1 K241395 Active System; Avenue8score 9.4 · 4 generations · no Class I recall
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070541 | Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IISummary page 2…Predicate OrthoCor Active Knee System ____ __________ ____ ____IVIVI Torino 111K070541 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Technology Deposit athermal RF… | 2008 |
| Kept off the family tree | K091640 | OrthoCor Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…IMD, 21 CFR 890.5710 PREDICATE: Ivivi K07054I (Torino II) ____ _______ ___ ____ ___ OrthoCor K091640 DEVICE DESCRIPTION The OrthoCor Active Knee System is a portable (battery operated) non-invasive shortwave diathermny medical d… |
What descends from it? (3)
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 18 years and passes through 3 companies; a new generation was cleared every 17.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152432 (Bioelectronics Corporation, 2017) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K070541.
How does its category compare?
All ILX devicesILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ILX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ILX
Too few ILX 510(k)s in any year since 2007 to give a median.
Recalls per year · ILX
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILX
1in 2025
MAUDE reports naming product code ILX, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
OrthoCor Knee System is indicated for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
Temporary relief of minor muscular and joint aches and pains associated with over-exertion, strains, sprains, and arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092044: Orthocor Knee System, Median, Large, X-Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092044
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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