510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K244039Substantially Equivalent

MedalOne Total Knee System

Suzhou MicroPort Orthorecon Co., Ltd., Suzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K244039 is the FDA 510(k) clearance record for MedalOne Total Knee System, a class II device, cleared for Suzhou Microport Orthorecon Co., Ltd. on under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). FDA records list one 510(k) clearance for Suzhou Microport Orthorecon Co., Ltd. As of , FDA records show no recalls naming K244039.

Clearance record

Decision date
Received
(60 days to decision)
Product code
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Suzhou Microport Orthorecon Co., Ltd. Bldg. 2 And 3, #151, Fengli St., Suzhou Industrial, Suzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JWH

Trailing 12 months
14 clearances under product code JWH in the twelve months to October 2026, September 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code JWH, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20261
September 20266
October 20260