# K040749: Modular Replacement System Cemented Stems

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jun 17, 2004 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952970 (1996). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952970: Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm, Howmedica Corp. (1996) Summary page 1.
- K965164: Howmedica Modular Replacement System-Proximal Femur, Howmedica Corp. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K972841: Modular Replacement System (MRS). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K241059: Pantheon Proximal Femur Reconstruction (PFR) System (2025), 0 descendants of its own
- K241716: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component (2024), 0 descendants of its own

## Recalls of this device
- Jan 30, 2009 · Not classified · Z-1251-2009: Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibi

## Indications for use
Femoral and/or proximal tibial replacement due to Trauma Failed previous prosthesis Tumor resection

Source page: https://510kreport.com/device/K040749
Methodology: https://510kreport.com/methodology