# K152084: Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Apr 29, 2016 after 277 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K935452 (1994). 69 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010367: Modification to Titanium Tri-Lock Hips Stem, DePuy Orthopaedics, Inc. (2001) Summary page 7.
- K103479: Novel Tapered Hip Stem, Stryker Corp. (2011) Summary page 7.
- K120578: Accolade II Hip Stem, Howmedica Osteonics (2012) Summary page 7.
- K803126: Exeter Total Hip System, Howmedica Corp. (1981) Summary page 7.
- K011623: Exeter Hip System with V40 Taper, Howmedica Osteonics Corp. (2001) Summary page 7.
- K110290: Exeter Hip Stem, Howmedica Osteonics Corp. (2011) Summary page 7.
- K974054: Distal Centralizer, Exeter II Hip System, Howmedica, Inc. (1997) Summary page 7.
- K042959: Depuy C-Stem Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2004) Summary page 7.
- K013350: Modification to Depuy C-Stem System, DePuy Orthopaedics, Inc. (2001) Summary page 7.
- K791125: Plug-Lok Cement Restirctor, Richard'S Medical Equip., Inc. (1979) Summary page 7.
- K001733: Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series & 1109 & 8109 Series, Zimmer, Inc. (2000) Summary page 7.

## Most influential descendants
- 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
- K220468: BENCOX Mirabo Cup System (2022), 1 descendant of its own

## Recalls of this device
- Oct 4, 2019 · Class II · Z-0496-2020: Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips fa

## Indications for use
Bencox M Stem (Bencox Hip 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 total hip arthroplasty The Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is intended for cemented use in total or partial hip arthroplasty and 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 The Centralizer is intended to be used with Bencox ID Cemented Stem to centralize the femoral stem within the intramedullary canal. The Bencox Bone Plug is intended to be used with cemented hip replacement procedures to control and restrict the flow of cement within the intramedullary canal.

Source page: https://510kreport.com/device/K152084
Methodology: https://510kreport.com/methodology