# K122099: Bencox II Stem, Bencox Metal Head

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: Oct 5, 2012 after 81 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: 7 generations back to K941847 (1994). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Indications for use
The Bencox Hip System is intended for cementless 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/K122099
Methodology: https://510kreport.com/methodology