# K112019: Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Oct 12, 2011 after 90 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P960047 (1997). 34 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 3.
- K003429: Malloy/Head Lateralized Press-Fit Femoral, Biomet, Inc. (2000) Summary page 3.
- K010243: Tri-Fit Femoral Stem, Corin USA (2001) Summary page 3.
- K993438: Metal on Metal Acetabular System, Biomet, Inc. (2000) Summary page 3.
- K003363: M2A 32MM Taper System, Biomet, Inc. (2000) Summary page 3.
- K972961: Stelkast Bipolar System, Stelkast Company (1997) Summary page 3.
- K051569: Ringloc BI-Polar Acetabular Component, Biomet, Inc. (2005) Summary page 3.
- K800207: Uhr UNIVERSAL6HIP Replacement, Osteonics Corp. (1980) Summary page 3.

## Most influential descendants
- K121665: Bencox Foret & Bencox Delta (2012), 8 descendants of its own
- 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

## Indications for use
The Bencox Bipolar Cup system is intended for cementless use in partial or total 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 hip arthroplasty.

Source page: https://510kreport.com/device/K112019
Methodology: https://510kreport.com/methodology