# K853250: Femorotibial Medullary Nail

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 12, 1986 after 195 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0333-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Source page: https://510kreport.com/device/K853250
Methodology: https://510kreport.com/methodology