# K211609: ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Aug 25, 2021 after 92 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: 11 generations back to K810258 (1981). 77 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101433: Depuy Attune Knee System, DePuy Orthopaedics, Inc. (2010) Summary page 4.
- K150090: Zimmer Persona Personalized Knee System, Zimmer, Inc. (2015) Summary page 4.

## Most influential descendants
- K262251: ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) (2026), 0 descendants of its own
- K253197: ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (2025), 0 descendants of its own

## Indications for use
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

Source page: https://510kreport.com/device/K211609
Methodology: https://510kreport.com/methodology