# K980609: Segmental Defect Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Metagen, LLC
- Decided: May 18, 1998 after 90 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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 K962553 (1996). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962553: EZ-Fix Midshaft Humeral Intramedullary Rod System, Biodynamic Technologies, Inc. (1996) Summary page 2.

## Most influential descendants
- K051965: Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System (2006), 3 descendants of its own
- K142451: OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System (2015), 1 descendant of its own
- K181026: OsteoBridge™ IDSF System (2018), 0 descendants of its own
- K101939: Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System (2010), 0 descendants of its own
- K984202: Howmedica Humeral Intercalary System (1999), 0 descendants of its own

## Indications for use
The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive destructive bone lesion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture. The Segmental Defect Replacement System, when used with bone cement, is indicated for pathologic fractures or impending pathologic fractures of the diaphysis of the humerus secondary to metastatic bone disease and hematologic malignancies.

Source page: https://510kreport.com/device/K980609
Methodology: https://510kreport.com/methodology