# K103756: Depuy Attune Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 15, 2011 after 82 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: 4 generations back to K943462 (1994). 12 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 1.
- K101433: Depuy Attune Knee System, DePuy Orthopaedics, Inc. (2010) Summary page 1.
- K910500: Howmedica Kinemax Plus Total Knee System, Howmedica Corp. (1991) Summary page 1.
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 1.

## Most influential descendants
- K202194: ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology (2020), 4 descendants of its own
- K232303: ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology (2023), 1 descendant of its own
- K261458: ATTUNE Total Knee System; ATTUNE Cementless Knee System (2026), 0 descendants of its own
- K242665: DePuy ATTUNE™ Total Knee System (2024), 0 descendants of its own
- K240678: ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology (2024), 0 descendants of its own

## Indications for use
The DePuy AttuneTm Total 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/K103756
Methodology: https://510kreport.com/methodology