# K221088: Anatomic Bone Plate

- Pathway: 510(k) (Traditional)
- Applicant: Double Medical Technology, Inc.
- Decided: Jan 18, 2023 after 280 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). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130108: Double Engine Bone Plate and Screw Systems, Xiamen Double Engine Medical Material Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K242348: Locking Screw,CoCrMo (2024), 0 descendants of its own

## Indications for use
The Anatomic Bone Plates are intended for the internal fixation of fractures (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral, Distal Ulnar Locking, Distal Radial Locking, VAL Proximal Tibia, VAL Distal Tibia, VAL Distal Lateral Fibular, VAL Distal Femoral, Pelvic Bone Plate), fracture dislocations (VAL Proximal Humeral), osteotomies, and mal/non-unions (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral) of the clavicle, pelvis, and the upper (i.e., humerus, ulna and radius) and lower (i.e., femur, tibia, and fibula) extremities. Additional plates included in the system with specific indications as follows: VAL (Variable Angle Locking) Distal Clavicle Plate is indicated for fractures of the shaft and lateral clavicle, malunions and non-unions ; VAL Distal Humeral Plate is indicated for fractures (including supracondylar), and nonunions ; VAL Distal Femoral Plate is indicated for distal femoral fractures (diaphyseal, supracondylar, and intra-articular); Pelvic Bone Plate is indicated for pelvic fractures (e.g., acetabular , iliac wing, and symphysis pubis).

Source page: https://510kreport.com/device/K221088
Methodology: https://510kreport.com/methodology