# K251892: MAXXOS P.A.C.E. Foot & Ankle Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Maxxos Medical GmbH
- Decided: Sep 8, 2025 after 80 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 K962616 (1996). 207 ancestors in all.
No later device cites it as a predicate yet.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162674: BioPro Foot Plating Systems, Biopro, Inc. (2017) Summary page 5.

## Indications for use
I. Forefoot System: The MAXXOS -Forefoot Plating System is "Indicated for Use" in fixation of small bones and small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient. The Forefoot System is not for Spinal Use. II. Mid/Hindfoot System: The MAXXOS - Mid/Hindfoot Plating System is "Indicated for Use" in fixation of medium/large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient. The Mid/Hindfoot System is not for Spinal Use. III. Ankle Fracture and Fusion System: The MAXXOS -Ankle Fracture and Fusion System is "Indicated for Use" in: 1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, perarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; 2). In intra- and extra articular fractures, osteotomies, medial malleolar fractures and non-unions of the mataphyseal and diaphyseal region of the distal fibula; 3). Fusion of the ankle. 4 ). In distal tibia/fibula long bones which include the metaphyseal and diaphyseal regions of the tiba and fibula in the ankle. The Ankle Fracture and Fusion System is not for Soinal Use.

Source page: https://510kreport.com/device/K251892
Methodology: https://510kreport.com/methodology