510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223548Substantially Equivalent

GMK Sphere & GMK SpheriKA Cementless

Medacta International SA, Castel San Pietro (Ch), CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223548 is the FDA 510(k) clearance record for GMK Sphere & GMK SpheriKA Cementless, a class II device, cleared for Medacta International S.A. on under FDA product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer). FDA records list 205 510(k) clearances for Medacta International S.A., from to . As of , FDA records show no recalls naming K223548.

Clearance record

Decision date
Received
(56 days to decision)
Product code
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation
21 CFR 888.3565
Device class
Class II
Review panel
Orthopedic
Applicant
Medacta International S.A. Strada Regina, Castel San Pietro (Ch), CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBH

Trailing 12 months
9 clearances under product code MBH in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MBH, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20262
October 20260