# K203341: ACS LD Uni FB Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Implantcast GmbH
- Decided: Jan 8, 2021 after 57 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K911802 (1992). 72 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063515: Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar Knee, Biomet Manufacturing, Inc. (2007) Summary page 4.
- K163700: Bodycad Unicompartmental Knee System, Bodycad Laboratories, Inc. (2017) Summary page 4.
- K181302: Bodycad Unicompartmental Knee System, Bodycad Laboratories, Inc. (2019) Summary page 4.
- K161741: GMK Uni, Medacta International S.A. (2017) Summary page 4.
- K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 4.

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

## Indications for use
The ACS® LD Uni FB Knee System is indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is single-use implant intended for implantation with bone cement.

Source page: https://510kreport.com/device/K203341
Methodology: https://510kreport.com/methodology