# K242045: Initia T3 Acetabular Hemispherical Shell System

- Pathway: 510(k) (Traditional)
- Applicant: Kyocera Medical Technologies, Inc.
- Decided: Apr 10, 2025 after 272 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K810258 (1981). 169 ancestors in all.
No later device cites it as a predicate yet.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160895: Initia Total Hip System & BIOCERAM AZUL (R) HEAD, Kyocera Medical Corporation (2016) Summary page 6.
- K132312: Renovis Tesera Trabecular Technology (T3) Acetabular Shell System, Renovis Surgical Technologies, LLC (2014) Summary page 6.

## Indications for use
The KMTI Hip Replacement System is indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5. Revision procedures where other treatment or devices have failed. The Initia T3 Acetabular Hemispherical Shell System is intended for cementless applications.

Source page: https://510kreport.com/device/K242045
Methodology: https://510kreport.com/methodology