# K140915: Excia Total Hip System

- Pathway: 510(k) (Special)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Jul 21, 2014 after 102 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: 9 generations back to K955033 (1996). 79 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092143: Excia Total Hip System M an ML Femoral Stem, Aesculap Implant Systems, Inc. (2009) Summary page 1.
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head, Aesculap, Inc. (2006) Summary page 1.
- (no number) Smith & Nephew Synergy Hip System: named in the summary without a submission number

## Most influential descendants
- K150062: Excia Total Hip System (2015), 1 descendant of its own
- K172235: CoreHip® System (2018), 0 descendants of its own

## Indications for use
The Excia Hip 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 ephiphysis - Patients suffering from disability due to previous fusion - Patients with acute femoral neck fractures The Excia Hip System is available with two (2) femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without pCaP®.

Source page: https://510kreport.com/device/K140915
Methodology: https://510kreport.com/methodology