# K072562: Microware Bone Plates and Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Microware Precision Co., Ltd.
- Decided: Dec 4, 2008 after 450 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.
25 later devices descend from it; 3 cite it directly.
0 of 29 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 2.
- K983873: Syntec-Taichung Non-Sterile DHS/DCS Plate System, Syntec Scientific Corp. (1998) Summary page 2.
- K063020: Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System, Intai Technology, Inc. (2006) Summary page 2.

## Most influential descendants
- 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
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own

## Indications for use
Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges). Microware DHS/DCS Plate System is provided non-sterile. Microware 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 fracture.

Source page: https://510kreport.com/device/K072562
Methodology: https://510kreport.com/methodology