# K101433: Depuy Attune Knee System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 10, 2010 after 203 days
- Product code: OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive)
- 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: 3 generations back to K943462 (1994). 10 ancestors in all.
114 later devices descend from it; 15 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943462: Darwin Knee System, Johnson & Johnson Professionals, Inc. (1994) Summary page 3.
- K950010: Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated, Johnson & Johnson Professionals, Inc. (1995) Summary page 1.
- K961685: P.F.C. Cruciate Retaining Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1996) Summary page 3.
- K032151: Depuy Sigma Tibial Inserts and CO-CR Tibial Trays, Depuy, Inc. (2003) Summary page 1.
- K040166: Depuy Sigma XLK Tibial Inserts, DePuy Orthopaedics, Inc. (2004) Summary page 3.
- K082500: Depuy Sigma CR-F Femoral Component, DePuy Orthopaedics, Inc. (2008) Summary page 3.
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 3.
- K922620: Amk Fixed Stem Cemented Tibial Tray, Depuy, Inc. (1992) Summary page 1.

## Most influential descendants
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K111433: Depuy Sttune (TM) PS Knee System (2011), 39 descendants of its own
- K140833: Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 26 descendants of its own
- K142404: iTotal Posterior Stabilized (PS) Knee Replacement System (2014), 24 descendants of its own
- K142161: Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 24 descendants of its own

## Indications for use
The DePuy Attune Knee System is intended for cemented use as a total knee replacement system. 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/K101433
Methodology: https://510kreport.com/methodology