510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K181635Substantially Equivalent

GMK Sphere CR Tibial Inserts

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

K181635 is the FDA 510(k) clearance record for GMK Sphere CR Tibial Inserts, a class II device, cleared for Medacta International S.A. 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 S.A., from to . As of , FDA records show no recalls naming K181635.

Clearance record

Decision date
Received
(63 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 S.A. Strada Regina, Castel San Pietro (Ch), CH
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