# K040128: Modification to Modular Replacement System (MRS) Humeral Stems

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 26, 2004 after 65 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: 2 generations back to K954559 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
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 1.
- K032264: Modular Replacement System (MRS) Humeral Stem, Howmedica Osteonics Corp. (2003) Summary page 1.

## 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 and K032264.

Source page: https://510kreport.com/device/K040128
Methodology: https://510kreport.com/methodology