# K103384: Escalade Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development
- Decided: Mar 16, 2011 after 118 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930712 (1993). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042565: Encompass Hip Stem, Tri-Plus Acetabular Shell, Tri-Plus DCM Liner, Ortho Development Corp. (2005) Summary page 1.
- K062148: Depuy Pinnacle Altrx Acetabular Cup Liner, DePuy Orthopaedics, Inc. (2006) Summary page 1.
- K000306: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 1.

## Most influential descendants
- K161080: Escalade Legend Acetabular Shell (2016), 1 descendant of its own
- K242833: Legend® Acetabular Shell (2024), 0 descendants of its own
- K183532: Latitud Hip Replacement System (2019), 0 descendants of its own

## Recalls of this device
- Dec 19, 2011 · Not classified · Z-0740-2012: Tip of hex-head screwdriver may break off during use in hip replacement procedure.

## Indications for use
The Escalade Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Escalade Acetabular Cup System is compatible with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the stem) and the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem). Total hip arthroplasty is indicated for the following conditions: 1. Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis. 2. Previously failed hip surgery. 3. Fractures of the femoral neck or head. 4. Avascular necrosis of the femoral head. 5. Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Source page: https://510kreport.com/device/K103384
Methodology: https://510kreport.com/methodology