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510(k) K203523

Fixone hybrid knotless anchor by Aju Pharm Co., Ltd. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 25, 2021
Date Received
December 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Aju Pharm Co., Ltd.

  • K233601 — Fixone Meniscal Repair (August 2, 2024)
  • K230892 — Fixone Biocomposite Anchor (June 9, 2023)
  • K222423 — Fixone All Suture Anchor (March 23, 2023)
  • K193497 — Fixone Biocomposite Interference Screw (January 5, 2021)
  • K192709 — Fixone All Suture Anchor (December 15, 2020)
  • K192484 — Fixone Biocomposite Anchor (March 11, 2020)
  • K192032 — Fixone Biocomposite Small Anchor (March 3, 2020)
  • K171299 — Fixone Biocomposite Anchor (August 24, 2017)
  • K162070 — JOINIX CANNULAR SYSTEM (March 16, 2017)

Other clearances for product code MAI

  • K254055 — OSSIOfiber® Suture Anchor (February 24, 2026)
  • K251680 — Biosteon® Screw (February 17, 2026)
  • K252946 — BioBrace® Extra-Articular Ligament Augmentation Kit (October 15, 2025)
  • K252022 — OSSIOfiber® Interference Screw (August 19, 2025)
  • K251309 — OSSIOfiber® Suture Anchor (May 27, 2025)
  • K250544 — Knotilus+ Biocomposite Knotless Anchor (May 23, 2025)
  • K250528 — Stryker AlphaVent™ Knotless SP Biocomposite Anchor (May 21, 2025)
  • K243760 — OSSIOfiber® Suture Anchor 2.5-3.5 mm (April 3, 2025)
  • K250526 — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (March 14, 2025)
  • K243790 — GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor (February 5, 2025)