# K240181: Clavicle and Scapula System

- Pathway: 510(k) (Traditional)
- Applicant: Auxein Medical Pvt., Ltd.
- Decided: Oct 9, 2024 after 260 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: 5 generations back to K000684 (2000). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051083: Acumed Scapula Congruent Bone Plate System, Acumed, LLC (2005) Summary page 5.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 5.
- K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 5.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 5.
- K203414: DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System, DePuy Synthes (2020) Summary page 5.
- K213059: Tibia and Fibula System, Auxein Medical Private Limited (2023) Summary page 5.
- K213108: Humerus & Ulna System, Auxein Medical Private Limited (2022) Summary page 5.

## Indications for use
3.5mm Wise-Lock Scapula Medial Border Plate Indicated to provide fixation during fractures, fusions, and osteotomies for the Scapula. 3.5mm Wise-Lock Clavicle Hook Plate Indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. 2.7/ 3.5mm Wise-Lock Superior Anterior Clavicle Plate with Lateral Extension Indicated for fixation of fractures, malunions, non-unions, and osteotomies for the clavicle. 3.5mm Wise-Lock S Clavicle Plate Indicated to provide fixation for fractures, fusion, or osteotomies for the clavicle.

Source page: https://510kreport.com/device/K240181
Methodology: https://510kreport.com/methodology