510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K152631Substantially Equivalent

MPO Total Knee Systems MR Labeling

Microport Orthopedics Inc., Arlington TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152631 is the FDA 510(k) clearance record for MPO Total Knee Systems MR Labeling, a class II device, cleared for Microport Orthopedics, Inc. on under FDA product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer). FDA records list 38 510(k) clearances for Microport Orthopedics, Inc., from to . As of , FDA records show no recalls naming K152631.

Clearance record

Decision date
Received
(190 days to decision)
Product code
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3530
Device class
Class II
Review panel
Orthopedic
Applicant
Microport Orthopedics, Inc. 5677 Airline Rd., Arlington TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRY

Trailing 12 months

FDA records hold no clearances under product code HRY in the trailing twelve months.

FDA records show no clearances under product code HRY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HRY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260