# K213108: Humerus & Ulna System

- Pathway: 510(k) (Traditional)
- Applicant: Auxein Medical Private Limited
- Decided: Nov 4, 2022 after 406 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: 4 generations back to K981372 (1998). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082625: Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates, Synthes (Usa) (2008) Summary page 7.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 7.

## Most influential descendants
- K240181: Clavicle and Scapula System (2024), 0 descendants of its own

## Indications for use
Specific Indications: 1. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate is intended for treating of Intraarticular Fracture of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus. 2. 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support is intended for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus. 3. 2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate 2.7/3.5mm Wise-Lock Dorsolateral Medial Distal Humerus Plate are indicated for treating of Intraarticular fractures of the distal humerus, Supracondylar fractures of the distal humerus and Non-unions of the distal humerus. 4. 3.5mm Wise-Lock Extra-Articular Distal Humerus Plate 3.5mm Wise-Lock Extra-Articular Distal Humerus Plate are indicated for fractures of the distal humerus. 5. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Short PHEELOS Short Indications • Dislocated two-, three-, and four-fragment fractures of the proximal humerus • Pseudarthroses in the proximal humerus • Osteotomies in the proximal humerus 6. PHEELOS-3.5mm Wise-Lock Proximal Humerus Plate, Long • As for PHEELOS Short, but for fractures extending to the shaft or without medial support. 7. 3.5mm Wise-Lock Proximal Humerus Plate The 3.5mm Wise-Lock Proximal Humerus Plate is intended for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus.3 8. 3.5mm Wise-Lock Periarticular Proximal Humerus Plate 3.5mm Wise-Lock Periarticular Proximal Humerus Plate are indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus. 9. 3.5mm Wise-Lock Olecranon Plate 3.5mm Wise-Lock Olecranon Plate is indicated for fixation of fractures, osteotomies and non-unions of the olecranon. 10. 3.5mm Wise-Lock Hook Plate 3.5mm Wise-Lock Hook Plate is indicated for fractures, osteotomies and non-unions of small bones including the ulna, radius, tibia and fibula. 11. 2.7mm Wise-Lock Screw, Self-Tapping (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 12. 3.5mm Wise-Lock Screw, Self-Tapping (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 13. 3.5mm Wise-Lock Screw, Self-Drilling, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 14. 3.5mm Wise-Lock Cancellous Screw, Full Thread, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 15. 3.5mm Wise-Lock Cancellous Screw, Short Thread, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 16. 3.5mm Cortical Screw, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 17. 4.0mm Cancellous Screw, Short Thread This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 18. 4.0mm Cancellous Screw, Full Thread This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury. 19. 2.7mm Cortical Screw, Self-Tapping, (Hex Head) This Screw is indicated for the fixation of bone and plate to produce compression in bones which is required to mend a bone injury.

Source page: https://510kreport.com/device/K213108
Methodology: https://510kreport.com/methodology