# K011504: Baumer Locking Nail

- Pathway: 510(k) (Traditional)
- Applicant: Baumer, S.A
- Decided: Aug 14, 2001 after 90 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Intramedullary nails are anatomic implants specially developed for osteosynthesis. Their objective is to stabilize and fix a fracture through intramedullary blocking. The “Baumer Locking Nail” is indicated to intramedullary fixation for fractures of the tibia (Tibial Locking Nail) and femur (Femoral Locking Nail). The device is for single use; it's should never be reused.

Source page: https://510kreport.com/device/K011504
Methodology: https://510kreport.com/methodology