# K220468: BENCOX Mirabo Cup System

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: May 18, 2022 after 90 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). 295 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 296 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.
- K150007: Modified Bencox Hip System, Corentec Co., Ltd. (2015) 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.
- K190904: Conformis BeneFIT Hip System, Conformis, Inc. (2019) Summary page 4.
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System, Zimmer, Inc. (2009) Summary page 4.

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

## Indications for use
Bencox Mirabo Cup System of Bencox Total Hip System is intended for Cementless use in partial or 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/K220468
Methodology: https://510kreport.com/methodology