# K223223: BENCOX Mirabo Z Cup Cortinium

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: Feb 27, 2023 after 133 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: 15 generations back to K810258 (1981). 330 ancestors in all.
No later device cites it as a predicate yet.
0 of 330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210614: BENCOX Mirabo Z Cup Cortinium, Corentec Co., Ltd. (2022) Summary page 4.
- K120924: Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw Hole Plug, Corentec Co., Ltd. (2012) Summary page 4.
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System, Corentec Co., Ltd. (2016) Summary page 4.
- K172806: Bencox Mirabo Cup System, Corentec Co., Ltd. (2017) Summary page 4.
- K220468: BENCOX Mirabo Cup System, Corentec Co., Ltd. (2022) Summary page 4.

## Indications for use
BENCOX Mirabo Z Cup Cortinium of BENCOX Total Hip System is intended for Cementless use in total hip arthroplasty in primary or revision surgery for the following conditions: a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis b. Inflammatory degenerative joint disease, such as rheumatoid arthritis c. Treatment of non-union, femoral neck fracture, and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques d. Patients with failed previous surgery where pain, deformity, or dysfunction persists e. Revision of previously failed total hip arthroplasty

Source page: https://510kreport.com/device/K223223
Methodology: https://510kreport.com/methodology