510(k) Report

FDA applicant

Orthocor Medical

Mccordsville, IN3 decisions2009–20130 recalls

FDA records 3 decisions for Orthocor Medical (Mccordsville, IN) from 2009 to 2013: 3 510(k) clearances. All are in product code ILX (Diathermy, Shortwave, For Use Other Than…). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Orthocor Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2009: 22013: 1
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Orthocor Medical by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orthocor Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K092044Orthocor Knee System, Median, Large, X-LargeOrthocor Medical · 20092cite it
  • K121702Orthocor Active Device Orthocor General Use Active DeviceOrthocor Medical · 20131cites it
  • K091996Orthocor Knee System BasicOrthocor Medical · 20091cites it

What has FDA decided for it lately?

  • K121702Orthocor Active Device Orthocor General Use Active DeviceOrthocor Medical · 2013
  • K092044Orthocor Knee System, Median, Large, X-LargeOrthocor Medical · 2009
  • K091996Orthocor Knee System BasicOrthocor Medical · 2009

All 3 as Orthocor Medical →