# K213059: Tibia and Fibula System

- Pathway: 510(k) (Traditional)
- Applicant: Auxein Medical Private Limited
- Decided: Jan 27, 2023 after 492 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: 1 generation back to K013248 (2001). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 9.

## Most influential descendants
- K240181: Clavicle and Scapula System (2024), 0 descendants of its own
- K232115: TDM Large Bone Plate and Screw System (2024), 0 descendants of its own

## Indications for use
Wise-Lock Tibia & Fibula System The Wise-Lock Tibia & Fibula System plates are intended for fracture fixation. Indications for the plates included in the system as follows: 3.5mm Wise-Lock Medial Distal Tibia Plate: Medial distal tibia plates are indicated for treating fractures of the tibia. 3.5mm Wise-Lock Proximal Tibia Plate: 3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia. 3.5mm Wise-Lock Medial Proximal Tibia Plate: The 3.5mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. 3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate: 3.5mm Wise-Lock Posterior Medial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia. 3.5mm Wise-Lock Anterolateral Distal Tibia Plate: 3.5mm Wise-Lock Anterolateral Distal Tibia Plate indicated for treating fractures of the tibia. 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia. 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia. 3.5mm Wise-Lock Lateral Distal Fibula Plate: The 3.5mm Wise-Lock Lateral Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula. 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia: The 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia is indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula. 3.5mm Wise-Lock Pilon Plate: The 3.5mm Wise-Lock Pilon Plate is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia. 3.5mm Wise-Lock Pilon Plate, Cruciform: 3.5mm Wise-Lock Pilon Plate, Cruciform is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia. 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate: The 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures Supracondylar fractures Intra-articular and extra-articular condylar fractures Non-unions, and Malunions 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate: The 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate is intended for fixation of fractures and osteotomies involving the tibia. The plate is indicated for the the follow: Treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures. To buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. The fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intra articular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures. 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate: The 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate is indicated for treatment of nonunions, malunions, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate: The 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies. 4.5/5.0mm Wise-Lock Proximal Tibia Plate: 4.5/5.0mm Wise-Lock Proximal Tibia Plate is indicated for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. AV-Wise Lock Ankle System The AV-Wise Lock Ankle System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused. Indications for plates included in the system are as follows: Medial and Anteromedial Distal Tibia Plates are indicated for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, Distal Tibia T Plates and Distal Tibia L Plates are indicated to buttress partial articular fractures and bone fragments of the distal tibia, and Lateral Distal Fibula Plates are indicated for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula. AV-Wise Lock Proximal Tibia Plates The AV-Wise Lock Proximal Tibia Plates are indicated to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies.

Source page: https://510kreport.com/device/K213059
Methodology: https://510kreport.com/methodology