# K243295: Initia Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Kyocera Medical Technologies, Inc.
- Decided: Jan 13, 2025 after 87 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120038: A200 Knee System, Renovis Surgical Technologies, LLC (2013) Summary page 5.
- K190122: Renovis A200 PS Knee System as part of the Renovis A200 Knee System, Renovis Surgical Technologies (2019) Summary page 5.

## Indications for use
The Initia Knee System is intended for use in total knee arthroplasty for the following indications: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is for cemented use only.

Source page: https://510kreport.com/device/K243295
Methodology: https://510kreport.com/methodology