E-CLASS DUAL MOBILITY INSERTS and DYNASTY DUAL MOBILITY LINERS
510(k) K200011
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200011 | Date1 Oct 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LPH
- FDA applicant
- Microport Orthopedics, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The E-Class Dual Mobility Inserts and Dynasty Dual Mobility Liners are semi-constrained metal/polymer hip prostheses designed for use in total hip arthroplasty. These devices are intended to reduce friction and improve joint mobility by incorporating dual-mobility technology, enhancing stability and range of motion in skeletally mature patients.
These components are supplied as uncemented, porous-coated implants for use with compatible acetabular shells and femoral heads. They are intended for primary or revision arthroplasty procedures, where all associated wear components must be replaced. The devices are classified under product code LPH and have received FDA 510(k) clearance as substantially equivalent to a predicate device, adhering to Class II special controls.
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of hip procedures are these dual mobility inserts and liners intended for, and how do they differ from standard implants?
The E-Class Dual Mobility Inserts and Dynasty Dual Mobility Liners are designed specifically for total hip arthroplasty procedures, including both primary and revision surgeries. They incorporate dual-mobility technology, which reduces friction and enhances joint stability and range of motion compared to standard implants. This design is particularly useful for skeletally mature patients who require improved mobility and reduced dislocation risk, as the dual-mobility feature allows for greater movement within the hip joint while maintaining stability.
Are these implants cemented or uncemented, and what does that mean for their placement in the body?
These devices are supplied as uncemented implants, meaning they are designed to be placed directly onto the patient’s bone without the use of bone cement. The porous coating on the components encourages bone ingrowth, helping to secure the implant in place over time. This approach is often preferred for revision surgeries or when bone quality is a concern, as it allows for better integration with the surrounding bone.
How are the E-Class Dual Mobility Inserts and Dynasty Dual Mobility Liners supplied, and do they require matching components?
These devices are supplied as standalone inserts and liners, intended for use with compatible acetabular shells and femoral heads from the same manufacturer. Since they are semi-constrained metal/polymer implants, they must be paired with the correct femoral head size and acetabular shell to ensure proper function and stability. The system is designed for total replacement of all associated wear components during surgery, ensuring optimal performance.
Are these implants single-use or reusable, and what considerations should be made for storage?
The E-Class Dual Mobility Inserts and Dynasty Dual Mobility Liners are single-use devices, meaning they are intended for one surgical procedure only. Proper storage is critical to maintain sterility and functionality. They should be stored in their original packaging, protected from moisture, extreme temperatures, and contamination, following the manufacturer’s guidelines to preserve their integrity until use.