# P160036: Hintermann Series H3 Total Ankle Replacement System

- Pathway: PMA
- Applicant: Dt Medtech, LLC
- Decided: Jun 4, 2019 after 1,014 days
- Product code: NTG (Prosthesis, Ankle, Uncemented, Non-Constrained)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 24, 2026 · Class II · Z-2399-2026: Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.

Source page: https://510kreport.com/device/P160036
Methodology: https://510kreport.com/methodology