# K200011: E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Oct 1, 2021 after 638 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
Longest line of descent: 12 generations back to K810258 (1981). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150522: G7 Dual Mobility System, Biomet, Inc. (2015) Summary page 4.
- K161190: G7 Dual Mobility System, Active Articulation System, Biomet, Inc. (2016) Summary page 4.

## Most influential descendants
- K240046: Ethylene Oxide Sterilization Supplier Change for MPO Hips (2024), 0 descendants of its own

## Indications for use
The DYNASTY® Dual Mobility Inserts and Liners, when used with compatible acetabular shells and femoral heads, are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. In revision arthroplasties, all devices associated with the wear couple must be removed and replaced. 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; 5) dislocation risks; 6) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement which are unmanageable by other techniques Dual Mobility Inserts and Liners are single use implants intended for uncemented arthroplasty.

Source page: https://510kreport.com/device/K200011
Methodology: https://510kreport.com/methodology