510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243480Substantially Equivalent

SuturePatch Tissue Reinforcement

Arthrex GmbH, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243480 is the FDA 510(k) clearance record for SuturePatch Tissue Reinforcement, a class II device, cleared for Arthrex, Inc. on under FDA product code OWX (Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon). FDA's definition for product code OWX reads: "For reinforcement of soft tissue where weakness exists in tendon repair". FDA records list 352 510(k) clearances for Arthrex, Inc., from to . As of , FDA records show no recalls naming K243480.

Clearance record

Decision date
Received
(202 days to decision)
Product code
OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Arthrex, Inc. 1370 Creekside Blvd., Naples FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWX

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