# K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Dec 5, 2016 after 126 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K810258 (1981). 198 ancestors in all.
6 later devices descend from it; 6 cite it directly.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152084: Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug, Corentec Co., Ltd. (2016) Summary page 5.
- K010367: Modification to Titanium Tri-Lock Hips Stem, DePuy Orthopaedics, Inc. (2001) Summary page 6.
- K120924: Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw Hole Plug, Corentec Co., Ltd. (2012) Summary page 5.
- K150007: Modified Bencox Hip System, Corentec Co., Ltd. (2015) Summary page 5.
- K000306: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 7.
- K062148: Depuy Pinnacle Altrx Acetabular Cup Liner, DePuy Orthopaedics, Inc. (2006) Summary page 7.

## Most influential descendants
- K172806: Bencox Mirabo Cup System (2017), 4 descendants of its own
- K182221: Bencox Mirabo Cup Multi Hole (2019), 3 descendants of its own
- K210614: BENCOX Mirabo Z Cup Cortinium (2022), 1 descendant of its own
- K220468: BENCOX Mirabo Cup System (2022), 1 descendant of its own
- K223223: BENCOX Mirabo Z Cup Cortinium (2023), 0 descendants of its own

## Recalls of this device
- Feb 27, 2017 · Class II · Z-1454-2017: Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.

## Indications for use
Bencox M Stem Lateralized & 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/K162127
Methodology: https://510kreport.com/methodology