# K121665: Bencox Foret & Bencox Delta

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Sep 25, 2012 after 111 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K941847 (1994). 101 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073337: Mectacer Biolox Forte-Femoral Heads, Medacta International S.A. (2008) Summary page 2.
- K062748: Modification: to Depuy Delta Ceramic Femoral Head, DePuy Orthopaedics, Inc. (2006) Summary page 2.
- K103431: Coren Total Hip System, Corentec Co., Ltd. (2011) Summary page 2.
- K112019: Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup, Corentec Co., Ltd. (2011) Summary page 2.

## Most influential descendants
- K150007: Modified Bencox Hip System (2015), 7 descendants of its own
- 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

## Indications for use
The Bencox Forte and Bencox Delta ceramic heads are 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 trochanteric 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 hip arthroplasty.

Source page: https://510kreport.com/device/K121665
Methodology: https://510kreport.com/methodology