# K252600: Pediatric Plating Platform I Small-Mini

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Oct 9, 2025 after 52 days
- Product code: HRS (Plate, 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
Longest line of descent: 13 generations back to K962616 (1996). 143 ancestors in all.
No later device cites it as a predicate yet.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140814: Evos Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 5.
- K170887: EVOS Small Fragment Plating System, Smith & Nephew, Inc. (2017) Summary page 5.
- K190253: EVOS Small Fragment Upper Extremity Plates Line Additions, Smith & Nephew, Inc. (2019) Summary page 5.
- K140431: Pediloc Fragment System, OrthoPediatrics Corp. (2014) Summary page 5.

## Indications for use
The Pediatric Plating Platform I Small-Mini is indicated for internal fracture fixation, osteotomies, mal-unions, and non-unions of bones and bone fragments of the appendicular skeleton appropriate for the implant size. The Pediatric Plating Platform I Small-mini is intended for children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which unfused growth plates will not be compromised by fixation, and adults. If used in the femur, tibia, humerus, patella, or pelvis the Pediatric Plating Platform I Small-Mini can only be used for non-load bearing stabilization and reduction.

Source page: https://510kreport.com/device/K252600
Methodology: https://510kreport.com/methodology