# K984202: Howmedica Humeral Intercalary System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Feb 5, 1999 after 73 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 K962553 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K980609: Segmental Defect Replacement System, Metagen, LLC (1998) Summary page 2.
- (no number) PMI's Proximal Humeral Segmental Replacement System (Biomet): named in the summary without a submission number

## Indications for use
The Howmedica Humeral Intercalary System is intended to be used in the management of segmental bone loss of the humerus in Oncology patients secondary to radical bone loss and/or resection due to tumors. This system is intended to be used in the management of shoulder girdle resections such as the Tikhoff-Linberg procedure, which involves removal of the bone and soft tissues of the proximal humerus and shoulder girdle. The Howmedica Humeral Intercalary System is intended to be used with bone cement. There is no glenoid component associated with this system.

Source page: https://510kreport.com/device/K984202
Methodology: https://510kreport.com/methodology