# K972401: Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jul 13, 1998 after 382 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.
78 later devices descend from it; 4 cite it directly.
2 of 79 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
- K003182: Orthogenesis LPS System (2001), 63 descendants of its own
- 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

## Indications for use
The Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments are presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the distal femur is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the distal femur/proximal tibia, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.

Source page: https://510kreport.com/device/K972401
Methodology: https://510kreport.com/methodology