510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250021Substantially Equivalent

Rotium

Nanofiber Solutions LLC, Dublin OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250021 is the FDA 510(k) clearance record for Rotium, a class II device, cleared for Nanofiber Solutions, LLC on under FDA product code OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon). FDA's definition for product code OWW reads: "For reinforcement of soft tissue where weakness exists during tendon repair procedures". FDA records list 6 510(k) clearances for Nanofiber Solutions, LLC, from to . As of , FDA records show no recalls naming K250021.

Clearance record

Decision date
Received
(55 days to decision)
Product code
OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Nanofiber Solutions, LLC 5164 Blazer Pkwy., Dublin OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWW

Trailing 12 months

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

FDA records show no clearances under product code OWW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OWW, 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