# K233980: ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Mar 21, 2024 after 94 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K943462 (1994). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111433: Depuy Sttune (TM) PS Knee System, DePuy Orthopaedics, Inc. (2011) Summary page 5.
- K170806: ATTUNE Cemented Tibial Base, Fixed Bearing, Depuy (Ireland) (2017) Summary page 5.
- K140881: Depuy Attune Knee System - Cementless CR and PS Femoral Componenets, Depuy (Ireland) (2015) Summary page 8.
- K091453: LPS Universal Tibial Hinge Inserts, Model 198727012-198727331, DePuy Orthopaedics, Inc. (2009) Summary page 11.
- K033959: LPS, Depuy, Inc. (2004) Summary page 11.
- K003182: Orthogenesis LPS System, Depuy, Inc. (2001) Summary page 11.
- K070267: Depuy GCK Tibial Components, DePuy Orthopaedics, Inc. (2007) Summary page 14.
- K070849: Depuy GCK Femoral and Tibial Components, DePuy Orthopaedics, Inc. (2007) Summary page 14.
- K061648: Depuy Graduated Compartmental Knee (GCK), DePuy Orthopaedics, Inc. (2006) Summary page 15.

## 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. 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, or a failed previous implant (provided that adequate bone is present). The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: * malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; * patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement; * revision cases for a failed previous prosthesis requiring extensive resection and replacement; * severe trauma requiring extensive resection and replacement. The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required. The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only. The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications. The SIGMA™ High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.

Source page: https://510kreport.com/device/K233980
Methodology: https://510kreport.com/methodology