# K003182: Orthogenesis LPS System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jun 27, 2001 after 259 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- 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: 1 generation back to K870730 (1987). 8 ancestors in all.
63 later devices descend from it; 8 cite it directly.
2 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870730: Noiles Total Knee Prosthesis, Joint Medical Products Corp. (1987) Summary page 2.
- K896048: S-Rom/Noiles Mark 3, Joint Medical Products Corp. (1990) Summary page 2.
- K905810: Noiles (TM) Total Knee Prosthesis, Modification, Joint Medical Products Corp. (1991) Summary page 2.
- K924940: Femoral & Tibial Augment Block, Joint Medical Products Corp. (1993) Summary page 2.
- K973087: Most Hex Intramedullary (I/M) Stem, Sulzer Orthopedics, Inc. (1997) Summary page 2.
- K933281: S.O.S. Proximal Femur, Wrightmedicaltechnologyinc (1994) Summary page 2.
- K972401: Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments, Howmedica Corp. (1998) Summary page 2.
- K965164: Howmedica Modular Replacement System-Proximal Femur, Howmedica Corp. (1997) Summary page 2.

## Most influential descendants
- K040281: LPS Metaphyseal Sleeve (Limb Preservation System) (2004), 54 descendants of its own
- K060515: Depuy PFC Sigma Knee Prosthesis (2006), 36 descendants of its own
- K063633: Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves (2007), 31 descendants of its own
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own
- K162422: Klassic Knee System (2016), 23 descendants of its own

## Indications for use
The Orthogenesis LPS System is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include: metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur; patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IID), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur; patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment; revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia. The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.

Source page: https://510kreport.com/device/K003182
Methodology: https://510kreport.com/methodology