# P150017: Cartiva Synthetic Cartilage Implant

- Pathway: PMA
- Applicant: Cartiva, Inc.
- Decided: Jul 1, 2016 after 427 days
- Product code: PNW (Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant)
- 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
- Oct 31, 2024 · Class II · Z-0598-2025: Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displacement, pain, nerve da

Source page: https://510kreport.com/device/P150017
Methodology: https://510kreport.com/methodology