# K170806: ATTUNE Cemented Tibial Base, Fixed Bearing

- Pathway: 510(k) (Traditional)
- Applicant: Depuy (Ireland)
- Decided: Jun 15, 2017 after 90 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943462 (1994). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 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.
- K032151: Depuy Sigma Tibial Inserts and CO-CR Tibial Trays, Depuy, Inc. (2003) Summary page 4.

## Most influential descendants
- K261458: ATTUNE Total Knee System; ATTUNE Cementless Knee System (2026), 0 descendants of its own
- K233980: ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (2024), 0 descendants of its own

## Recalls of this device
- Feb 22, 2021 · Class II · Z-1314-2021: Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affe

## 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/K170806
Methodology: https://510kreport.com/methodology