# K150007: Modified Bencox Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: May 4, 2015 after 122 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: 10 generations back to K810258 (1981). 137 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 144 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 5.
- K103431: Coren Total Hip System, Corentec Co., Ltd. (2011) Summary page 5.
- K974685: Osteonics Polyethylene Acetabular Components, Osteonics Corp. (1998) Summary page 6.
- K021911: Trident Crossfire Polyuethylene Liners, Howmedica Osteonics Corp. (2002) Summary page 6.
- K112019: Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup, Corentec Co., Ltd. (2011) Summary page 5.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 6.
- K121665: Bencox Foret & Bencox Delta, Corentec Co., Ltd. (2012) Summary page 5.
- K112115: Mectacer Biolox (R) Delta Femoral Heads, Medacta International (2011) Summary page 6.
- K071535: Biolox Delta Ceramic Femoral Head, Zimmer, Inc. (2007) Summary page 6.

## Most influential descendants
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System (2016), 6 descendants of its own
- 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

## Indications for use
The Modified Bencox Hip System is intended for use in total or partial 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/K150007
Methodology: https://510kreport.com/methodology