Class Class II
Arthrex iBalance Partial Knee System (K251453)
Description
Arthrex iBalance Partial Knee System by Arthrex, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251453
Clearance Date2025-07-01
Clearance TypeTraditional
Product CodeHSX
Regulation Number888.3520
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251453
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Arthrex iBalance Partial Knee System (K251453) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200433 | iBalance UKA Tibial Tray Implant | Arthrex, Inc. | 2020 |
| K171365 | Arthrex Knee Systems | Arthrex, Inc. | 2017 |
| K161060 | Arthrex iBalance UKA System Vitamin E Tibial Bearing | Arthrex, Inc. | 2016 |
| K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | Arthrex, Inc. | 2016 |
| K143047 | Arthrex iBalance Patella Implant, Dome | Arthrex, Inc. | 2014 |
| K073120 | ACCIN PATELLOFEMORAL SYSTEM | Accelerated Innovation, LLC | 2008 |
| K063782 | ACCIN UNI-KNEE SYSTEM | Accin Corporation | 2007 |
Trace the full predicate network for K251453
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.