# K091453: LPS Universal Tibial Hinge Inserts, Model 198727012-198727331

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 12, 2009 after 86 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K242871: ATTUNE™ Revision Hinge Knee (2024), 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
- K191779: Attune Revision LPS Inserts (2019), 0 descendants of its own

## Indications for use
The DePuy LPS 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; a 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. It 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 and diaphyseal sleeves are intended for either cemented or cementless applications.

Source page: https://510kreport.com/device/K091453
Methodology: https://510kreport.com/methodology