# K213005: Apollo Ankle Fracture Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Glw Medical, Inc.
- Decided: Mar 11, 2022 after 172 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 K082320 (2008). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163044: ORTHOLOC® 3Di Ankle Fracture Plating System, Wrightmedicaltechnologyinc (2017) Summary page 5.

## Most influential descendants
- K221489: Artemis Proximal Femoral Nail System (2022), 0 descendants of its own

## Indications for use
Apollo™ Ankle Fracture Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as: » Lateral Malleolar Fractures » Syndesmosis Injuries » Medial Malleolar Fractures » Bi-Malleolar Fractures » Tri-Malleolar Fractures » Posterior Malleolar Fractures » Distal Anterior Tibia Fractures » Vertical Shear Fractures of the Medial Malleolus » Pilon Fractures » Distal Tibia Shaft Fractures » Distal Fibula Shaft Fractures » Distal Tibia Periarticular Fractures » Medial Malleolar Avulsion Fractures » Lateral Malleolar Avulsion Fractures Apollo Locking Screws are intended for use with Apollo’s Plating Systems. Apollo non-Locking Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device. Apollo washer is intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments. Apollo 1/3 tubular plates are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Source page: https://510kreport.com/device/K213005
Methodology: https://510kreport.com/methodology