# K203472: KMTI Hip Replacement System

- Pathway: 510(k) (Special)
- Applicant: Kyocera Medical Technologies, Inc.
- Decided: Apr 2, 2021 after 128 days
- Product code: OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, 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: 10 generations back to K931641 (1994). 96 ancestors in all.
No later device cites it as a predicate yet.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132312: Renovis Tesera Trabecular Technology (T3) Acetabular Shell System, Renovis Surgical Technologies, LLC (2014) Summary page 4.
- K141676: Renovis Surgical Porous Acetabular Cup System, Renovis Surgical Technologies, Inc. (2014) Summary page 4.

## Indications for use
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 KMTI A400 Hip System is intended for cementless applications unless used with the KMTI Cemented Hip Stem. The KMTI Porous Coated Acetabular Shell System is intended for cementless applications. In addition, the KMTI Porous Coated Acetabular Shell and Universal liners can be used with: * The Kyocera Corporation (“KYOCERA”) Initia Total Hip System femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head. » The KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head. » The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (28-40mm) femoral head. The Cemented Hip Stem is intended for cemented applications. The KMTI Tesera Trabecular Technology (T3) Acetabular Shell System is intended for cementless applications. In addition, the KMTI T3 Acetabular Shell and Universal Liners can be used with: * The KYOCERA Initia femoral stem mated with KYOCERA CoCr (28—40mm) or BIOCERAM AZUL (28-40mm) femoral head. * The KMTI femoral stem mated with KYOCERA CoCr (28—40mm) or BIOCERAM AZUL (28-40mm) femoral head. » The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (28-40mm) femoral head. The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition: * The KYOCERA 28mm CoCr and 28mm BIOCERAM AZUL femoral heads and Initia femoral stem can be used with the KMTI 28mm ID Bipolar Head. » The KYOCERA Initia femoral stem can be used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head. The Bipolar Head is for uncemented use only. Bipolar outer heads are not for use with acetabular shells and liners.

Source page: https://510kreport.com/device/K203472
Methodology: https://510kreport.com/methodology