# K101939: Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Merete Medical GmbH
- Decided: Oct 7, 2010 after 87 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
Longest line of descent: 3 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)
- K051965: Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System, Merete Medical GmbH (2006) Summary page 1.
- K853250: Femorotibial Medullary Nail, Zimmer, Inc. (1986) Summary page 1.
- K050938: Knee Fusion Nail, Smith & Nephew, Inc. (2005) Summary page 1.

## Recalls of this device
- Sep 18, 2020 · Class II · Z-0435-2021: Product may be mislabeled.

## Indications for use
Intramedullary knee arthrodesis Indications include: 1. Irretrievably failed total knee arthroplasty 2. Limb salvage 3. Oncology surgery 4. Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treatment of choice The intramedullary rods can be fixed with interlocking screws without or with bone cement.

Source page: https://510kreport.com/device/K101939
Methodology: https://510kreport.com/methodology