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MPO Total Knee Systems MR Labeling

by MicroPort Orthopedics Inc.

510(k) K152631

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152631 Date23 Mar 2016ClearedStatusActive

Official records

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  • Withdrawn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
HRY
FDA applicant
Microport Orthopedics, Inc.
Device class
Class II
Regulation
21 CFR Part 888.3530
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 MPO Total Knee Systems MR Labeling are passive orthopedic implants classified as knee joint femorotibial metal/polymer semi-constrained cemented prostheses. These devices are designed for knee arthroplasty, providing structural support and restoring function to the knee joint through metallic femoral components, ultra-high-molecular-weight polyethylene (UHMWPE) tibial inserts, and cobalt chrome or titanium alloy tibial bases. The components are available in both porous and non-porous variants to accommodate varying clinical needs.

The system is intended for use in orthopedic surgical settings and is supplied as a sterile, single-use implant. Components are MRI conditional, allowing for safe imaging under specific conditions outlined in the labeling. Sizes and configurations are standardized to match anatomical requirements, and the device carries FDA 510(k) clearance under regulation 21 CFR 888.3530. Storage and handling follow standard orthopedic implant protocols to maintain sterility and integrity prior to surgical use.

From the manufacturer

Manufacturer's product page: Understanding Knee Replacement

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