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510(k) K252022

OSSIOfiber® Interference Screw by OSSIO , Ltd. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2025
Date Received
June 30, 2025
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 OSSIO , Ltd.

  • K254055 — OSSIOfiber® Suture Anchor (February 24, 2026)
  • K251309 — OSSIOfiber® Suture Anchor (May 27, 2025)
  • K243760 — OSSIOfiber® Suture Anchor 2.5-3.5 mm (April 3, 2025)
  • K241932 — OSSIOfiber® Compression Staple (August 28, 2024)
  • K241277 — OSSIOfiber® Threaded Trimmable Fixation Nail (July 3, 2024)
  • K233198 — OSSIOfiber® Threaded Trimmable Fixation Nails (March 8, 2024)
  • K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimm (December 1, 2023)
  • K233302 — OSSIOfiber® Compression Staple (November 16, 2023)
  • K230750 — OSSIOfiber® Cannulated Trimmable Fixation Nail (September 13, 2023)
  • K221193 — OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm (December 23, 2022)

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)
  • 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)
  • K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (December 3, 2024)