Class Class II
ACS® LD FB Knee System (K234044)
Description
ACS® LD FB Knee System by Implantcast GmbH, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234044
Clearance Date2024-09-06
Clearance TypeTraditional
Product CodeJWH
Regulation Number888.3560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234044
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. ACS® LD FB Knee System (K234044) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173884 | Unity Total Knee System | Corin U.S.A. Limited | 2018 |
| K102437 | GMK REVISION KNEE SYSTEM | Medacta International S.A. | 2010 |
| K090988 | GMK TOTAL KNEE SYSTEM | Medacta International S.A. | 2009 |
| K042343 | SCORPIO NRG KNEE SYSTEM | Howmedica Osteonics Corp. | 2005 |
| K041591 | SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS | Howmedica Osteonics Corp. | 2004 |
Trace the full predicate network for K234044
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.