# K122382: Dynasty Biofoam Shell

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 22, 2012 after 77 days
- Product code: MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous)
- 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
Longest line of descent: 1 generation back to K082924 (2009). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082924: Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner, Wrightmedicaltechnologyinc (2009) Summary page 1.

## Most influential descendants
- K170288: BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell (2017), 2 descendants of its own
- K243574: Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique (2025), 1 descendant of its own
- K253728: EVOLUTION® AM BIOFOAM® Tibial System (2026), 0 descendants of its own
- K201157: Prime BIOFOAM® Multi-Hole Shells (2021), 0 descendants of its own
- K202705: Prime and DYNASTY® Additive Manufacturing Shells (2021), 0 descendants of its own

## Indications for use
1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The DYNASTY® BIOFOAM®)Shell is intended for cementless hip arthroplasty.

Source page: https://510kreport.com/device/K122382
Methodology: https://510kreport.com/methodology