# K181026: OsteoBridge™ IDSF System

- Pathway: 510(k) (Special)
- Applicant: Merete GmbH
- Decided: Oct 17, 2018 after 182 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962553 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142451: OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System, Merete Medical GmbH (2015) Summary page 4.

## Recalls of this device
- Sep 18, 2020 · Class II · Z-0437-2021: Product may be mislabeled.
- Sep 18, 2020 · Class II · Z-0438-2021: Product may be mislabeled.
- Sep 18, 2020 · Class II · Z-0436-2021: Product may be mislabeled.

## Indications for use
- Long-term stabilization of major bone defects resulting from o Radical bone loss due to tumors and/or metastases o Bone resections following tumors and/or metastases - For use only in the diaphyseal region of humerus, tibia and femur

Source page: https://510kreport.com/device/K181026
Methodology: https://510kreport.com/methodology