# K191641: AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws

- Pathway: 510(k) (Traditional)
- Applicant: Industrias Medicas Sampedro S.A.S
- Decided: Sep 16, 2019 after 89 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 K792022 (1979). 108 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162841: VariAx Distal Radius Plating System, VariAx 2 System, Stryker GmbH (2017) Summary page 5.

## Most influential descendants
- K242343: BPS Wrist Fracture System (2024), 1 descendant of its own
- K250498: BPS Wrist Fracture System (2025), 0 descendants of its own
- K220199: AFFINITY Proximal Tibia System (2022), 0 descendants of its own

## Indications for use
AFFINITY - Variable Angle Distal Radius System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.

Source page: https://510kreport.com/device/K191641
Methodology: https://510kreport.com/methodology