# K103431: Coren Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Corentec Co., Ltd.
- Decided: Jul 21, 2011 after 240 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: 6 generations back to K941847 (1994). 55 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042249: CLS Spotorno Stem, Zimmer Austin, Inc. (2004) Summary page 2.
- K010839: CLS Varus Stem/CLS 135 Stem, Sulzer Orthopedics, Inc. (2001) Summary page 2.
- K042344: Excia Total Hip System, Aesculap, Inc. (2005) Summary page 2.
- K052026: Lineage a-Class Poly Liner, Wrightmedicaltechnologyinc (2005) Summary page 2.
- K993438: Metal on Metal Acetabular System, Biomet, Inc. (2000) Summary page 2.
- K003363: M2A 32MM Taper System, Biomet, Inc. (2000) Summary page 2.

## Most influential descendants
- K121665: Bencox Foret & Bencox Delta (2012), 8 descendants of its own
- K120924: Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw Hole Plug (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

## Indications for use
The COREN® Total Hip System is intended for 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.

Source page: https://510kreport.com/device/K103431
Methodology: https://510kreport.com/methodology