510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K171640Substantially Equivalent

M-ARS ACL: Anatomic Ribbon Surgery System

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

K171640 is the FDA 510(k) clearance record for M-ARS ACL: Anatomic Ribbon Surgery System, a class II device, cleared for Medacta International S.A. on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list 205 510(k) clearances for Medacta International S.A., from to . As of , FDA records show no recalls naming K171640.

Clearance record

Decision date
Received
(143 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
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 MBI

Trailing 12 months
31 clearances under product code MBI in the twelve months to October 2026, March 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code MBI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20263
February 20261
March 20269
April 20261
May 20264
June 20261
July 20264
August 20262
September 20263
October 20260