# K051965: Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Merete Medical GmbH
- Decided: Jun 16, 2006 after 331 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: 2 generations back to K962553 (1996). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934643: Ace Humeral Nail, Ace Orthopedic Manufacturing Co. (1994) Summary page 1.
- K882443: Zindrick IM Rod Instruments, Buckman Co., Inc. (1988) Summary page 1.
- K871539: Zindrick IM Rod, Buckman Co., Inc. (1987) Summary page 1.
- K933518: Synthes Unreamed Humeral Nail (Urhn), Synthes (Usa) (1994) Summary page 1.
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 1.
- K893377: Russell-Taylor Intramedullary Knee Fusion Nails, Richards Medical Co., Inc. (1989) Summary page 1.
- K980609: Segmental Defect Replacement System, Metagen, LLC (1998) Summary page 1.
- K954559: Howmedicca Modular Proximal Humerus Replacement System, Howmedica Corp. (1996) Summary page 1.
- K853250: Femorotibial Medullary Nail, Zimmer, Inc. (1986) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The device is intended to be used in the management of segmental diaphyseal bone loss of either humerus or tibia or femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.

Source page: https://510kreport.com/device/K051965
Methodology: https://510kreport.com/methodology