# K032264: Modular Replacement System (MRS) Humeral Stem

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 8, 2003 after 16 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- 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 K954559 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954559: Howmedicca Modular Proximal Humerus Replacement System, Howmedica Corp. (1996) Summary page 2.

## Most influential descendants
- K040128: Modification to Modular Replacement System (MRS) Humeral Stems (2004), 0 descendants of its own

## Indications for use
The subject humeral stems (MRS Humeral Stems without porous coating) are intended for use with the components of the Modular Replacement System Humeral System. This device is intended for use in patients requiring reconstruction of the proximal humerus due to extensive bone loss as a result of tumor resection secondary to primary or metastatic skeletal lesions. This device is intended for use with bone cement. This is the same intended use as the predicate device in premarket notification K954559.

Source page: https://510kreport.com/device/K032264
Methodology: https://510kreport.com/methodology