# K172235: CoreHip® System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implants Systems, LLC
- Decided: Mar 28, 2018 after 246 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: 11 generations back to K955033 (1996). 128 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150062: Excia Total Hip System, Aesculap Implant Systems, LLC (2015) Summary page 4.
- K140915: Excia Total Hip System, Aesculap Implant Systems, LLC (2014) Summary page 4.
- K092143: Excia Total Hip System M an ML Femoral Stem, Aesculap Implant Systems, Inc. (2009) Summary page 4.
- K090299: Biolox Option Ceramic Femoral Head and Metha XL Heads, Aesculap Implant Systems (2009) Summary page 4.
- K081973: Metha Short Stem Hip System; Modular Hip System; Excia Hip System, Aesculap Implant Systems, Inc. (2008) Summary page 4.
- K082991: Biolox Delta Ceramic Femoral Head, Aesculap Implant Systems, Inc. (2008) Summary page 4.
- K062684: Excia Total Hip System 36MM Ceramic Head, Aesculap, Inc. (2006) Summary page 4.
- K061699: EXCIA, Aesculap, Inc. (2006) Summary page 4.
- K061344: Excia Total Hip System Lateral Offset, Aesculap, Inc. (2006) Summary page 4.
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head, Aesculap, Inc. (2006) Summary page 4.
- K060437: Excia Total Hip System with U-Cap, Aesculap, Inc. (2006) Summary page 4.
- K042344: Excia Total Hip System, Aesculap, Inc. (2005) Summary page 4.

## Indications for use
The CoreHip® System is intended to replace a hip joint. The device is intended for: • Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur • Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis • Patients suffering from disability due to previous fusion • Patients with acute femoral neck fractures The CoreHip® System is available with two (2) types of femoral stem fixation. One stem is manufactured from CoCrMo and is intended for cemented fixation and the other femoral stem is manufactured from Ti with Plasmapore® and is intended for uncemented (pressfit) fixation.

Source page: https://510kreport.com/device/K172235
Methodology: https://510kreport.com/methodology