# K000764: Pediatric Fixation Rods

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Apr 6, 2000 after 28 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.
13 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K082375: Orthopediatrics Pediflex Flexible Nail System (2008), 10 descendants of its own
- K143355: The Simple Locking IntraMedullary (SLIM) System (2015), 6 descendants of its own
- K192710: The Simple Locking Intramedullary (Slim) System (2020), 5 descendants of its own
- K231266: Pediatric Nailing Platform  Tibia (2023), 2 descendants of its own
- K250623: Pediatric Nailing Platform  Tibia Pediatric Nailing Platform  Femur (2025), 1 descendant of its own

Source page: https://510kreport.com/device/K000764
Methodology: https://510kreport.com/methodology