# K251975: Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Ignite Orthomotion
- Decided: Sep 2, 2025 after 68 days
- Product code: NJD (Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3535
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K943462 (1994). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242307: ACHIEVE Partial Knee System, Ignite Orthomotion (2024) Summary page 5.

## Indications for use
The ACHIEVE PARTIAL KNEE SYSTEM is intended for unicompartmental knee arthroplasty of the medial and/or lateral femorotibial compartments to treat one or more of the following conditions: • Moderately disabling joint disease of the knee resulting from painful osteo or post traumatic arthritis. • Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty. • As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. Fixation Methods Tibial trays and femoral components with engineered porous surfaces are intended for cemented or cementless use. Tibial trays and femoral components without engineered porous surfaces are intended for cemented use only.

Source page: https://510kreport.com/device/K251975
Methodology: https://510kreport.com/methodology