Home / 510(k) Clearances / K250544

510(k) K250544

Knotilus+ Biocomposite Knotless Anchor by Stryker Endoscopy — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2025
Date Received
February 25, 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 Stryker Endoscopy

  • K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with (February 18, 2026)
  • K260108 — L12 LED Light Source with AIM (February 12, 2026)
  • K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management Sys (January 13, 2026)
  • K253888 — MOLLI 2 System (December 31, 2025)
  • K252010 — SPY Laparoscope (July 24, 2025)
  • K252012 — SPY Cystoscope/Hysteroscope (July 18, 2025)
  • K250528 — Stryker AlphaVent™ Knotless SP Biocomposite Anchor (May 21, 2025)
  • K241401 — Connected OR Hub with Device and Voice Control; SDC4K Information Management Sys (August 15, 2024)
  • K240407 — ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-S (March 7, 2024)
  • K240174 — 1688 4K Camera System with Advanced Imaging Modality (February 22, 2024)

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)
  • 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)