# K210614: BENCOX Mirabo Z Cup Cortinium

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: May 24, 2022 after 449 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: 14 generations back to K810258 (1981). 288 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120924: Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw Hole Plug, Corentec Co., Ltd. (2012) Summary page 4.
- K000306: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 4.
- K093646: Depuy Pinnacle with Gription Acetabular Cups, DePuy Orthopaedics, Inc. (2009) Summary page 4.
- K150790: REDAPT Porous Acetabular Shell and Cemented Liner, Smith & Nephew, Inc. (2015) Summary page 4.
- K061253: Reflection 3 Acetabular System, Smith & Nephew, Inc. (2006) Summary page 4.
- K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 4.
- K182502: Alteon Acetabular Cup System, Exactech, Inc. (2019) 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.
- K182221: Bencox Mirabo Cup Multi Hole, Corentec Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K223223: BENCOX Mirabo Z Cup Cortinium (2023), 0 descendants of its own

## 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/K210614
Methodology: https://510kreport.com/methodology