# K063020: Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Intai Technology, Inc.
- Decided: Dec 14, 2006 after 73 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: 1 generation back to K983495 (1998). 2 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983495: Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420, Syntec Scientific Corp. (1998) Summary page 1.
- K983873: Syntec-Taichung Non-Sterile DHS/DCS Plate System, Syntec Scientific Corp. (1998) Summary page 1.

## Most influential descendants
- K072562: Microware Bone Plates and Bone Screws (2008), 25 descendants of its own
- K092493: GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate System (2010), 14 descendants of its own
- K171904: Tandry Locking Plate System (2018), 11 descendants of its own
- K110086: Ifs Profile Plates, Screws, and Washers (2011), 5 descendants of its own
- K161894: SurgTech Trauma System (2017), 3 descendants of its own

## Indications for use
The Bone Plate and Bone Screw System and the DHS/DCS Plate System are provided non-sterile. The Bone Plate and Bone Screw System 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), and small bone (metacarpals, 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.

Source page: https://510kreport.com/device/K063020
Methodology: https://510kreport.com/methodology