# K221787: Auxein's DHS/DCS Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Auxein Medical Private Limited
- Decided: Nov 30, 2023 after 527 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 3 generations back to K791619 (1979). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071852: Aap Aps System, Aap Implantate AG (2007) Summary page 5.
- K052677: Synthes Universal Locking Trochanter Stabilization Plate (Ultsp), Synthes (Usa) (2005) Summary page 6.
- K840954: Dynamic Condylar Screw or D.C.S., Synthes (Usa) (1984) Summary page 6.
- K914546: Angled Blade Plate, Synthes (Usa) (1991) Summary page 6.
- K791619: Dynamic Hip Screw, Synthes (Usa) (1979) Summary page 6.

## Indications for use
The DHS/DCS Plate System is intended for use in treating fractures of femoral head (Dynamic Hip Plates) and condylar part of the femur (Dynamic Condylar Plates). Specific indications, which are dependent on the angle of the plate, include: 130°-135°: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric. 95°: distal and intercondylar fractures of the femur.

Source page: https://510kreport.com/device/K221787
Methodology: https://510kreport.com/methodology