# K090786: Kens Internal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Kens Finemedtech Sdn. Bhd
- Decided: Jun 18, 2009 after 87 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: 2 generations back to K983495 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063020: Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System, Intai Technology, Inc. (2006) Summary page 1.

## Most influential descendants
- K111008: Microware Bone Plates and Bone Screw (2012), 0 descendants of its own

## Indications for use
The devices of KENS INTERNAL FIXATION SYSTEM are provided NON-STERILE. The Bone Plate, Bone Screw is intended for use in fixation of fractures to the various bones, including the clavicle, pelvis, scapula, calcaneus, long bone ( humerus, ulna, radius, femur, tibia, and fibula), an small bone ( metacarplas, metatarsals, and phalanges). The DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures. Pin and Wire are indicated for use in fracture fixation, for healing of comminuted bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.

Source page: https://510kreport.com/device/K090786
Methodology: https://510kreport.com/methodology