# K061699: EXCIA

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Aug 18, 2006 after 63 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K042334: Allura 3D-CA, Release 1, Philips Medical Systems North America Co. (2004). Our reading of the summary gave K042334, FDA’s number for Allura 3D-CA, Release 1 (Philips Medical Systems North America Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Acetabular Cups (Plasmacup® SC)”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K163577: Ecofit® Hip System (2017), 9 descendants of its own
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own
- K203420: EcoFit® Hip System (2021), 4 descendants of its own
- K210678: implaFit® hip stems (2022), 3 descendants of its own
- K240834: EcoFit® short stem cementless cpTi (2024), 1 descendant 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 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/K061699
Methodology: https://510kreport.com/methodology