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510(k) K250021

Rotium by Nanofiber Solutions, LLC — Product Code OWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2025
Date Received
January 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

For reinforcement of soft tissue where weakness exists during tendon repair procedures.

Other clearances by Nanofiber Solutions, LLC

  • K241912 — BIOCHARGE (July 29, 2024)
  • K231641 — Rotium Bioresorbable Wick (July 5, 2023)
  • K201414 — Rotium Bioresorbable Wick (June 25, 2020)
  • K183236 — Rotium Bioresorbable Wick (March 11, 2019)
  • K173544 — Phoenix Wound Matrix (March 2, 2018)

Other clearances for product code OWW

  • K251655 — VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (July 18, 2025)
  • K242187 — BioBrace® (November 27, 2024)
  • K241906 — BioBrace® Reinforced Implant (July 29, 2024)
  • K240817 — VersaWrap (June 14, 2024)
  • K222220 — SpinMedix Absorbable Fibrous Membrane (July 6, 2023)
  • K230316 — FlexBand; FlexPatch; FlexBand Plus (May 26, 2023)
  • K203267 — The BioBrace Implant (April 30, 2021)
  • K160364 — VersaWrap Tendon Protector (June 10, 2016)
  • K121216 — STR GRAFT (November 21, 2012)