510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011172Substantially Equivalent

Arthrex Bio-Transfix

Arthrex GmbH, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011172 is the FDA 510(k) clearance record for ARTHREX BIO-TRANSFIX, a class II device, cleared for Arthrex, Inc. on under FDA product code MNU (Staple, Absorbable). FDA records list 352 510(k) clearances for Arthrex, Inc., from to . As of , FDA records show no recalls naming K011172.

Clearance record

Decision date
Received
(63 days to decision)
Product code
MNU Staple, Absorbable
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Arthrex, Inc. 2885 S. Horseshoe Dr., Naples FL
510(k) summary
Summary
Third party review
No

Clearances, product code MNU

Trailing 12 months

FDA records hold no clearances under product code MNU in the trailing twelve months.

FDA records show no clearances under product code MNU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MNU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260