# K140881: Depuy Attune Knee System - Cementless CR and PS Femoral Componenets

- Pathway: 510(k) (Traditional)
- Applicant: Depuy (Ireland)
- Decided: Feb 13, 2015 after 312 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943462 (1994). 16 ancestors in all.
3 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)
- K101433: Depuy Attune Knee System, DePuy Orthopaedics, Inc. (2010) Summary page 4.
- K111433: Depuy Sttune (TM) PS Knee System, DePuy Orthopaedics, Inc. (2011) Summary page 4.
- K062654: Depuy Sigma Cruciate Retaining Porocoat Femoral Components, DePuy Orthopaedics, Inc. (2006) 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
- K201347: DePuy ATTUNE™ Total Knee System (2020), 0 descendants of its own

## Recalls of this device
- Jun 12, 2015 · Class II · Z-2145-2015: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off
- Jun 12, 2015 · Class II · Z-2139-2015: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off
- Jun 12, 2015 · Class II · Z-2141-2015: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off
- Jun 12, 2015 · Class II · Z-2146-2015: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off
- Jun 12, 2015 · Class II · Z-2143-2015: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off
- Jun 12, 2015 · Class II · Z-2140-2015: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off
- Jun 12, 2015 · Class II · Z-2144-2015: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off
- Jun 12, 2015 · Class II · Z-2138-2015: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off
- Jun 12, 2015 · Class II · Z-2137-2015: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off
- Jun 12, 2015 · Class II · Z-2142-2015: Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off

## Indications for use
The ATTUNE Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE 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 (provided that adequate bone is present).

Source page: https://510kreport.com/device/K140881
Methodology: https://510kreport.com/methodology