# K071417: Depuy LPS Diaphyseal and Metaphyseal Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 2, 2007 after 73 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: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K870730 (1987). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003182: Orthogenesis LPS System, Depuy, Inc. (2001) Summary page 1.
- K040281: LPS Metaphyseal Sleeve (Limb Preservation System), DePuy Orthopaedics, Inc. (2004) Summary page 1.
- K934457: Stability Hip Stem with Porocoat, Depuy, Inc. (1994) Summary page 1.

## Most influential descendants
- K202248: Attune Revision Sleeve LPS Femoral Adaptors (2020), 1 descendant of its own
- K253197: ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (2025), 0 descendants of its own

## Recalls of this device
- Jan 4, 2013 · Class I · Z-0828-2013: DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleev
- Jan 4, 2013 · Class I · Z-0829-2013: DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleev
- Jan 4, 2013 · Class I · Z-0830-2013: DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleev
- Jan 4, 2013 · Class I · Z-0831-2013: DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleev

## Indications for use
The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with distal femoral, proximal femoral, and proximal tibial replacements. The metaphyseal sleeve is intended to enhance the fit and fill of the metaphyseal region of the distal femur with femoral replacements. 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; * 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 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 diaphyseal and metaphyseal sleeves are intended for either cemented or cementless applications.

Source page: https://510kreport.com/device/K071417
Methodology: https://510kreport.com/methodology