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Prime BIOFOAM Multi-Hole Shells

by MicroPort Orthopedics Inc.

510(k) K201157

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201157 Date24 Aug 2021ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MBL
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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Prime BIOFOAM Multi-Hole Shells are classified as Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous. These acetabular components are designed to provide structural support and integration within the pelvis during hip replacement surgery, facilitating osseointegration through porous surface design and biofoam material properties.

Intended for use in orthopedic procedures, these shells are supplied sterile and intended for single-use. They are part of the Prime Acetabular Hip System and are regulated under FDA 510(k) clearance (K201157) with a classification of Class II. The device is manufactured by MicroPort Orthopedics Inc. and includes multiple registration numbers for tracking and compliance.

From the manufacturer

The Prime acetabular cup system is the next step in the evolution of the successful Dynasty® acetabular cup system. The system is optimized for a highly cross-linked ultra-high molecular weight polyethylene bearing surface, eliminating the compromises associated with modularity to accommodate alternative bearing surfaces.

Source: microportortho.com

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of hip replacement surgeries are the Prime BIOFOAM Multi-Hole Shells designed for, and how do they support integration with the pelvis?

    The Prime BIOFOAM Multi-Hole Shells are designed specifically for use in orthopedic hip replacement procedures as semi-constrained, uncemented acetabular components. They are engineered to provide structural support within the pelvis and promote osseointegration—the natural process where bone grows into the implant—through their porous surface design and biofoam material properties. This design helps stabilize the implant and encourages long-term fixation without the need for bone cement.

  • Are the Prime BIOFOAM Multi-Hole Shells intended for single-use or can they be reused after sterilization?

    The Prime BIOFOAM Multi-Hole Shells are explicitly supplied sterile and intended for single-use only. This is a standard practice for orthopedic implants to ensure patient safety and prevent cross-contamination, particularly in sterile surgical environments.

  • How do I verify the regulatory compliance and clearance status of these shells before purchasing?

    The Prime BIOFOAM Multi-Hole Shells are regulated under the FDA’s 510(k) clearance process with the classification K201157 and a decision code of SESE (Substantially Equivalent). They fall under the Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous category. To verify compliance, check the registration numbers (e.g., 2245304, 3009173317, etc.) listed in the OpenFDA database or confirm with MicroPort Orthopedics, Inc. via their contact details provided in the submission.

  • What materials are used in the construction of these shells, and how does the porous design contribute to their function?

    The Prime BIOFOAM Multi-Hole Shells are composed of a metal/polymer combination, which provides the necessary strength and flexibility for hip implants. The porous surface design enhances their function by allowing bone tissue to grow into the pores, improving stability and integration with the patient’s pelvis. This porous structure mimics natural bone, facilitating osseointegration and long-term fixation.

  • How should these shells be stored to maintain their sterility and integrity before use?

    Since the Prime BIOFOAM Multi-Hole Shells are supplied sterile, they should be stored in their original, unopened packaging in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. Follow the manufacturer’s storage instructions to preserve sterility and prevent contamination before surgical use.