# K221150: Advanced Bone Plate

- Pathway: 510(k) (Traditional)
- Applicant: Double Medical Technology, Inc.
- Decided: Jan 25, 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: 13 generations back to K954385 (1996). 183 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141527: Depuy Synthes Variable Angle Locking Hand System, Synthes USA (2015) Summary page 5.
- K103243: 2.4MM VA-LCP Intercarpal Fusion System, Synthes (Usa) (2011) Summary page 5.
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System, Wrightmedicaltechnologyinc (2015) Summary page 5.
- K090692: Ortholoc 2.0/2.4 Plate System, Wrightmedicaltechnologyinc (2009) Summary page 5.
- K171852: DARCO Locking Bone Plate System, Wrightmedicaltechnologyinc (2017) Summary page 5.
- K142121: Valor Hindfoot Fusion Nail System, Wrightmedicaltechnologyinc (2014) Summary page 5.
- K130108: Double Engine Bone Plate and Screw Systems, Xiamen Double Engine Medical Material Co., Ltd. (2013) Summary page 5.
- K141383: Acumed Hand Fracture System, Acumed, LLC (2014) Summary page 5.
- K151277: Airlock® osteosynthesis plate system, Novastep (2015) Summary page 5.
- K222194: Baby Gorilla®/Gorilla® Plating System, Paragon 28, Inc. (2022). Cleared while this submission was under review Summary page 5.
- K132898: A.L.P.S. Calcaneal Plating System, Biomet Manufacturing Corp (2013) Summary page 5.
- K132886: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 5.

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

## Indications for use
The Advanced Bone Plate (AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is indicated for internal fixation. Specific indications for the plates included in the system as follows: The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is indicated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of adults and adolescents (age 12-21 years) in which growth plates have fused or will not be crossed by fixation. The ITVAL Foot & Ankle VAL System is indicated for internal fixation (fractures, osteotomies, fusions, nonunions, malunions, small fragment replantations) of the foot and ankle in adults and adolescents (age 12-21 years) possessing normal or osteopenic bone where growth plates have fused or will not be crossed by fixation. The Distal Fibular VAL Plate is indicated for internal fixation (fractures, osteotomies, nonunions, malunions, small fragment replantations) of the distal fibula of adults and adolescents (age 12-21 years) where growth plates have fused or will not be crossed by fixation.

Source page: https://510kreport.com/device/K221150
Methodology: https://510kreport.com/methodology