510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K121416Substantially Equivalent

Gmk Sphere

Medacta International SA, Camarillo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121416 is the FDA 510(k) clearance record for GMK SPHERE, a class II device, cleared for Medacta International on under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). FDA records list 205 510(k) clearances for Medacta International, from to . As of , FDA records show no recalls naming K121416.

Clearance record

Decision date
Received
(70 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
Medacta International 4725 Calle Quetzal Unit B, Camarillo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JWH

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