# K014197: Synthes High Tibial Osteotomy Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 21, 2002 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Synthes High Tibial Osteotomy Plate is intended for closing wedge high tibial osteotomies for treatment of bone and joint deformities and misalignment caused by injury or disease such as osteoarthritis.

Source page: https://510kreport.com/device/K014197
Methodology: https://510kreport.com/methodology