# K042565: Encompass Hip Stem, Tri-Plus Acetabular Shell, Tri-Plus DCM Liner

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Apr 11, 2005 after 202 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
44 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K072857: Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot (2008), 39 descendants of its own
- K080885: Medacta Total Hip Prosthesis System - Line Extension (2008), 22 descendants of its own
- K103721: Mpact Acetabular System (2011), 21 descendants of its own
- K122641: Mpact Extension (2012), 14 descendants of its own
- K093944: Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S (2010), 12 descendants of its own

## Indications for use
The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only. 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis. 2. Previously failed surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of the femoral head. 5. Non-union of proximal femoral neck fractures. 6. Treatment of fractures that are unmanageable using other forms of therapy. 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Source page: https://510kreport.com/device/K042565
Methodology: https://510kreport.com/methodology