Dynasty Shell, Dynasty A-Class Crosslinked Poly Liner, Biolox Delta Femoral Head
510(k) K140043
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140043 | Date3 Apr 2014 | 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- Withdrawn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
- LZO
- FDA applicant
- Microport Orthopedics, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Dynasty Shell, Dynasty A-Class Crosslinked Poly Liner, Biolox Delta Femoral Head is a crosslinked polyethylene acetabular liner designed for use in total hip arthroplasty. It is paired with a Biolox Delta femoral head, a ceramic bearing component, to form a low-friction articulation within the hip joint, reducing wear and extending implant longevity.
This device is intended for use in primary or revision hip arthroplasty procedures and is supplied sterile for single-use. The liner is crosslinked to enhance durability and resistance to wear, and it is compatible with both cemented and cementless fixation methods. The FDA has granted 510(k) clearance (K140043) under the Traditional 510(k) Review process, classifying it as substantially equivalent to a predicate device. Storage and handling must adhere to sterile medical device protocols.
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of hip replacement surgeries can this device be used for, and why is it designed this way?
The Dynasty Shell liner is approved for both primary total hip arthroplasty (first-time hip replacements) and revision surgeries (replacements for failed implants). It’s designed with crosslinked polyethylene to reduce wear and extend the lifespan of the implant, which is particularly beneficial in revision cases where durability is critical. The pairing with a Biolox Delta femoral head (a ceramic component) further lowers friction, helping to preserve the joint’s function over time.
Is this device meant to be used with cement or without cement in the hip joint, and how does that affect its use?
The Dynasty Shell liner is compatible with both cemented and cementless fixation methods, meaning it can be secured to the pelvis using bone cement or press-fit techniques. This flexibility allows surgeons to choose the approach that best fits the patient’s anatomy and clinical needs, whether that’s for stability, bone preservation, or other factors. The liner’s design supports these methods without compromising its performance.
How is this device supplied, and what precautions should be taken when handling it?
The Dynasty Shell liner is supplied sterile for single-use only, meaning it must not be reused or reprocessed after opening. Handling must follow sterile medical device protocols to prevent contamination. This includes proper storage (e.g., in a clean, dry environment away from direct sunlight) and using aseptic techniques during surgery to maintain sterility until implantation.
What regulatory pathway was followed for this device, and what does that mean for its safety and equivalence?
This device received FDA 510(k) clearance (K140043) under the Traditional 510(k) Review process, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as an existing approved product, ensuring it meets safety and effectiveness standards. The clearance was granted in 2014 after review by the Orthopedic (OR) Advisory Committee.