# K234044: ACS® LD FB Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Sep 6, 2024 after 260 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K941847 (1994). 95 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173884: Unity Total Knee System, Corin U.S.A. Limited (2018) Summary page 5.
- K994128: Scorpio Total Stablizer (TS) Total Knee System, Howmedica Osteonics Corp. (2000) Summary page 5.
- K011643: Scorpio CR Superflex Tibial Insert, Howmedica Osteonics Corp. (2001) Summary page 5.
- K041591: Scorpio-Flex Posterior Stabilized Tibial Insert Components, Howmedica Osteonics Corp. (2004) Summary page 5.
- K042343: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2005) Summary page 5.
- K090988: GMK Total Knee System, Medacta International S.A. (2009) Summary page 5.
- K102437: GMK Revision Knee System, Medacta International S.A. (2010) Summary page 5.

## Most influential descendants
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## Indications for use
General total knee arthroplasty indications include: Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis Post-traumatic loss of knee joint configuration and function Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament. The ACS® LD FB Knee System is intended for cemented use, single use only. The ACS® LD FB Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

Source page: https://510kreport.com/device/K234044
Methodology: https://510kreport.com/methodology