# K061344: Excia Total Hip System Lateral Offset

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Aug 2, 2006 after 79 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K955033 (1996). 71 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042344: Excia Total Hip System, Aesculap, Inc. (2005) Summary page 1.
- K060437: Excia Total Hip System with U-Cap, Aesculap, Inc. (2006) Summary page 1.
- K040191: Bicontact Hip Stem and Femoral Head, Aesculap (2004) Summary page 1.
- K991123: Perfecta RS Lateralized Hip Stem, Bridge Hip System, Wrightmedicaltechnologyinc (1999) Summary page 1.
- K972641: Dual Offset Perfecta Imc Hip Stem, Wrightmedicaltechnologyinc (1997) Summary page 1.

## Most influential descendants
- K092143: Excia Total Hip System M an ML Femoral Stem (2009), 3 descendants of its own
- K140915: Excia Total Hip System (2014), 2 descendants of its own
- 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 and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necosis 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 Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without p CaP®.

Source page: https://510kreport.com/device/K061344
Methodology: https://510kreport.com/methodology