# K011810: Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial Bearing

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Sep 7, 2001 after 88 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: 1 generation back to K896048 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- 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.
- (no number) Orthogenesis LPS system: named in the summary without a submission number

## Most influential descendants
- K062301: Depuy LPS Proximal Tibial Component (2006), 0 descendants of its own

## Indications for use
The Orthogenesis LPS 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; o 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/K011810
Methodology: https://510kreport.com/methodology