# K251618: MOTO Partial Knee System Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jul 24, 2025 after 58 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: 6 generations back to K880155 (1988). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213071: MOTOTM Partial Knee & MOTO PFJ Systems Extension, Medacta International S.A. (2021) Summary page 5.
- K133940: Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays), Biomet UK, Ltd. (2014) Summary page 5.
- K162084: MOTO Partial Knee System, Medacta International S.A. (2017) Summary page 5.
- K183029: MOTO Partial Knee System, Medacta International S.A. (2019) Summary page 5.

## Indications for use
MOTO Medial, MOTO Lateral and MOTO Sphere Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

Source page: https://510kreport.com/device/K251618
Methodology: https://510kreport.com/methodology