# K111008: Microware Bone Plates and Bone Screw

- Pathway: 510(k) (Special)
- Applicant: Microware Precision Co., Ltd.
- Decided: May 2, 2012 after 387 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: 3 generations back to K983495 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072562: Microware Bone Plates and Bone Screws, Microware Precision Co., Ltd. (2008) Summary page 1.
- K090786: Kens Internal Fixation System, Kens Finemedtech Sdn. Bhd (2009) Summary page 1.
- K012945: Synthes 2.4 MM Cannulated Screw, Synthes (Usa) (2001) Summary page 1.
- K013806: Synthes Metallic Spiked Washers, Synthes (Usa) (2002) Summary page 1.
- K052483: Synthes (Usa) Spherical Washers, Synthes (Usa) (2005) Summary page 1.

## 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 Bone Plates and Bone Screws Accessonies: I1. The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone. 2. The spherical washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone. In addition, it can be applicable on the insertion at acute angles. 3. The spiked washer is used for ligament reattachment or fixation. 4. The support screw is anchored in cancellous bone by its thread. It supports the countersink head of a cannulated screw in cancellous bone.

Source page: https://510kreport.com/device/K111008
Methodology: https://510kreport.com/methodology