# K963325: Synthes Titanium (TI) Alloy High Tibial Osteotomy (Hto) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 25, 1997 after 214 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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

## Most influential descendants
- K190750: DePuy Synthes Plates and Screws Portfolio (2019), 0 descendants of its own

## Indications for use
Synthes Ti Alloy HTO System is an instrument and implant system intended to correct leg malalignments causing unicompartmental osteoarthritis, by correction of the tibial component.

Source page: https://510kreport.com/device/K963325
Methodology: https://510kreport.com/methodology