# K092044: Orthocor Knee System, Median, Large, X-Large

- Pathway: 510(k) (Traditional)
- Applicant: Orthocor Medical
- Decided: Dec 18, 2009 after 165 days
- Product code: ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903675 (1991). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070541: Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II, Ivivi Technologies, Inc. (2008) Summary page 2.

## Cited in the summary but 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.

## Most influential descendants
- K152432: ActiPatch (R) (2017), 1 descendant of its own
- K241395: Active System; Avenue8 (2024), 0 descendants of its own
- K192234: ActiPatch (2020), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K092044
Methodology: https://510kreport.com/methodology