# K962894: Synthes High Tibial Osteotomy (Hto) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 17, 1996 after 145 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 its predicate without a number.
- (no number) Howmedica's Alta Metaphyseal L-Plate: named in the summary without a submission number

## Indications for use
Synthes HTO System is an instrument and implant system intended for high tibial osteotomies to correct leg malaignments causing unicompartmental osteoarthritis.

Source page: https://510kreport.com/device/K962894
Methodology: https://510kreport.com/methodology