# K211385: KeriFlex® MCP and PIP Finger Joint Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Keri Medical SA
- Decided: Jul 27, 2022 after 449 days
- Product code: KYJ (Prosthesis, Finger, Constrained, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3230
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970544 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083107: Modification to Depuy Neuflex Pip Finger, DePuy Orthopaedics, Inc. (2009) Summary page 4.
- K970544: Depuy Dupont Orthopaedics Finger Joint Prosthesis, Depuy, Inc. (1997) Summary page 4.

## Indications for use
The KeriFlex® MCP and KeriFlex® PIP Finger Joint Prostheses are indicated for cementless replacement of the metacarpophalangeal (MCP) and interphalangeal (PIP) joints, respectively, where disabled by rheumatoid, degenerative or traumatic arthritis.

Source page: https://510kreport.com/device/K211385
Methodology: https://510kreport.com/methodology