# K151762: PediatrOS RigidTack/FlexTack

- Pathway: 510(k) (Traditional)
- Applicant: Merete Medical GmbH
- Decided: Dec 28, 2015 after 182 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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: 1 generation back to K031493 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031493: Growth Guidance Plate, University of Utah/School of Medicine (2003) Summary page 4.
- (no number) Blount Zimmalloy staple: named in the summary without a submission number

## Most influential descendants
- K220190: The GIRO Growth Modulation System (2022), 0 descendants of its own

## Recalls of this device
- Jan 18, 2022 · Class II · Z-0650-2022: Incorrect marketing label (25 mm) was applied to product size 20 mm.

## Indications for use
The PediatrOSTM RigidTackTM / FlexTackTM bone staples are indicated for pediatric patients (children/ adolescents) with angular deformities or leg length discrepancies. Therefore PediatrOSTM RigidTackTM / FlexTackTM is intended to redirect the angle of growth of long bones and to correct leg length discrepancies by inhibition of longitudinal growth of the physis (growth plate) in growing children and adolescents. Specific pediatric conditions/diseases for which the devices will be indicated include: x Valgus, varus, or flexion, extension, deformities of the knee (femur and/or tibia) x Valgus or varus deformities of the elbow (humerus) x Leg length discrepancies

Source page: https://510kreport.com/device/K151762
Methodology: https://510kreport.com/methodology