# K211866: Bencox THR System

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: Jul 14, 2021 after 28 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: 12 generations back to K810258 (1981). 199 ancestors in all.
No later device cites it as a predicate yet.
0 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System, Corentec Co., Ltd. (2016) Summary page 5.

## Indications for use
BENCOX Total Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions: • non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis; • Inflammatory degenerative joint disease, such as rheumatoid arthritis; • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; • patients with failed previous surgery where pain, deformity, or dysfunction persists; • revision of previously failed total hip arthroplasty.

Source page: https://510kreport.com/device/K211866
Methodology: https://510kreport.com/methodology