Prime and DYNASTY Additive Manufacturing Shells

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K202705 ↗

FDA Product Code

OQG

FDA applicant

Microport Orthopedics, Inc.

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from MicroPort Orthopedics Inc. →

• What types of hip replacement procedures are these shells designed for, and how do they differ from standard hip prostheses?

  The Prime and DYNASTY® Additive Manufacturing Shells are semi-constrained, cemented hip prostheses made from metal and polymer materials, enhanced with additive manufacturing to create porous structures. These shells are specifically designed to improve osseointegration (bone integration) and stability during hip replacement surgeries. Unlike standard hip prostheses, they incorporate customizable, porous coatings to promote better bone attachment, which can be particularly beneficial for patients requiring enhanced fixation or those with specific anatomical challenges.

• Are these shells reusable or single-use, and how should they be handled to maintain sterility?

  The Prime and DYNASTY® Additive Manufacturing Shells are explicitly designed for single-use only. They are intended for sterile operating environments, meaning they must remain unopened and uncontaminated until use. Proper handling includes maintaining sterile packaging until implantation and adhering to standard surgical aseptic techniques to prevent cross-contamination.

• What sizes and configurations are available, and how do I determine the correct fit for a patient?

  These shells come in a variety of sizes and configurations, as indicated by the extensive list of registration numbers (e.g., 3010375065, 3004748528, etc.). The specific sizes and models are tailored to match different anatomical requirements and surgical needs. To determine the correct fit, consult the manufacturer’s sizing guides or work with an orthopedic specialist who can select the appropriate shell based on preoperative imaging and patient anatomy.

• How are these shells regulated, and what does the FDA 510(k) clearance mean for their use?

  The Prime and DYNASTY® Additive Manufacturing Shells are regulated under the FDA’s 510(k) clearance process, specifically under clearance number K202705. This classification means the device has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets applicable safety and performance standards for hip prostheses. Clinicians and buyers can rely on this clearance as evidence of regulatory compliance for use in hip replacement procedures.

• What storage conditions should be followed to ensure the shells remain effective until use?

  While the exact storage conditions aren’t detailed in the provided data, standard practices for sterile, single-use medical devices like these shells typically require protection from moisture, extreme temperatures, and physical damage. They should be stored in their original, sealed packaging in a clean, dry environment as specified by the manufacturer’s instructions for use (IFU). Always verify the IFU for precise storage guidelines to maintain sterility and functionality.