# K140043: Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Apr 3, 2014 after 85 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K072656 (2008). 4 ancestors in all.
10 later devices descend from it; 3 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)
- K130376: Dynasty Acetabular System with Ceramic, Wrightmedicaltechnologyinc (2013) Summary page 1.
- K002149: Lineage Acetabular System, Wrightmedicaltechnologyinc (2000) Summary page 1.
- K052026: Lineage a-Class Poly Liner, Wrightmedicaltechnologyinc (2005) Summary page 2.

## Most influential descendants
- K142119: Procotyl L-O Acetabular System (2015), 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
- K240834: EcoFit® short stem cementless cpTi (2024), 1 descendant of its own
- K223103: BethaLoc® stem cementless HA (2023), 1 descendant of its own

## Indications for use
The DYNASTYS Acetabular System is intended for use in total hip erthroplasty for reduction or relief of pain andor improved hip function in skeletally matulre patients. 1. non-inflammuratory degenerativejoint disease such as osteoarthrfids, evascular necrosis, ankylosis, proflusio acetabuli, and painfful hip dysplasia. 2. inflammatory degenerativejoint disease such as rheumatoid arthritis; 3. correction of fuznctional deformnity; and, 4. revision procedures where other treatments or devices have faled Shells with BIOFOAMW) metal foam coating are intended only for u=cemnented arthmoplasty. Modular shells with porous metal bead coating may be used in either cemented or uncemented artliroplasty.

Source page: https://510kreport.com/device/K140043
Methodology: https://510kreport.com/methodology