# K223828: BENCOX Delta Option Heads

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Mar 16, 2023 after 85 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: 9 generations back to K810258 (1981). 92 ancestors in all.
No later device cites it as a predicate yet.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192416: BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System, Zimmer GmbH (2019) Summary page 4.

## Indications for use
BENCOX Delta Option Heads of BENCOX Total 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 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 total hip arthroplasty

Source page: https://510kreport.com/device/K223828
Methodology: https://510kreport.com/methodology