# K042344: Excia Total Hip System

- Pathway: 510(k) (Abbreviated)
- Applicant: Aesculap, Inc.
- Decided: Mar 16, 2005 after 198 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941847 (1994). 49 ancestors in all.
198 later devices descend from it; 17 cite it directly.
0 of 247 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040191: Bicontact Hip Stem and Femoral Head, Aesculap (2004) Summary page 2.
- K022077: 36MM V40 Femoral Head Components (Lfit and Non-Lfit), Howmedica Osteonics Corp. (2002) Summary page 2.
- K030373: Alloclassic Zweymueller SL/SLL Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 2.
- K031474: SC Total Hip System, Orthopedic Alliance, LLC (2003) Summary page 2.
- K022902: Smith & Nephew Hip System, Smith & Nephew, Inc. (2002) Summary page 2.
- K031495: Pinnacle Duofix HA Acetabular Cup Prosthesis, DePuy Orthopaedics, Inc. (2003) Summary page 2.
- K013475: Trident Porous Titanium Acetabular Component with Peri-Apatite Coating, Howmedica Osteonics Corp. (2001) Summary page 2.

## Most influential descendants
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head (2006), 90 descendants of its own
- K060437: Excia Total Hip System with U-Cap (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own
- K070981: Search Evolution (LC) Total Knee System (Plasmapore) (2007), 79 descendants of its own
- K081023: Evolis Total Knee System (2008), 78 descendants of its own

## Recalls of this device
- Oct 10, 2007 · Not classified · Z-0436-2008: Sterility (package integrity) Compromised: Device package damaged during shipment
- Oct 10, 2007 · Not classified · Z-0438-2008: Sterility (package integrity) Compromised: Device package damaged during shipment
- Oct 10, 2007 · Not classified · Z-0437-2008: Sterility (package integrity) Compromised: Device package damaged during shipment
- Oct 10, 2007 · Not classified · Z-0439-2008: Sterility (package integrity) Compromised: Device package damaged during shipment
- Oct 10, 2007 · Not classified · Z-0442-2008: Sterility (package integrity) Compromised: Device package damaged during shipment
- Oct 10, 2007 · Not classified · Z-0443-2008: Sterility (package integrity) Compromised: Device package damaged during shipment
- Oct 10, 2007 · Not classified · Z-0444-2008: Sterility (package integrity) Compromised: Device package damaged during shipment
- Oct 10, 2007 · Not classified · Z-0440-2008: Sterility (package integrity) Compromised: Device package damaged during shipment
- Oct 10, 2007 · Not classified · Z-0441-2008: Sterility (package integrity) Compromised: Device package damaged during shipment
- Oct 10, 2007 · Not classified · Z-0445-2008: Sterility (package integrity) Compromised: Device package damaged during shipment

## 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 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 CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.

Source page: https://510kreport.com/device/K042344
Methodology: https://510kreport.com/methodology