510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251618Substantially Equivalent

MOTO Partial Knee System Extension

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

K251618 is the FDA 510(k) clearance record for MOTO Partial Knee System Extension, a class II device, cleared for Medacta International S.A. on under FDA product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer). FDA records list 205 510(k) clearances for Medacta International S.A., from to . As of , FDA records show no recalls naming K251618.

Clearance record

Decision date
Received
(58 days to decision)
Product code
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3520
Device class
Class II
Review panel
Orthopedic
Applicant
Medacta International S.A. Strada Regina, Castel San Pietro, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSX

Trailing 12 months
2 clearances under product code HSX in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HSX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260