# K102505: Hto Plating System

- Pathway: 510(k) (Special)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Nov 24, 2010 after 84 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: 2 generations back to K973812 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080992: Aesculap Implant Systems High Tibial Osteotomy Plating System, Aesculap Implant Systems, Inc. (2008) Summary page 1.

## Indications for use
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.

Source page: https://510kreport.com/device/K102505
Methodology: https://510kreport.com/methodology