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510(k) K202153

Responsive Arthroscopy Suture Anchor System by Responsive Arthroscopy, LLC — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2020
Date Received
August 3, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Responsive Arthroscopy, LLC

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  • K230094 — Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors (August 25, 2023)
  • K222763 — Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors (October 13, 2022)
  • K203121 — Responsive Arthroscopy Thunderbolt System (April 27, 2021)
  • K202569 — Responsive Arthroscopy Interference Screw System (September 23, 2020)
  • K190446 — Responsive Arthroscopy Wedge Push-In Suture Anchors (March 27, 2019)
  • K181076 — Responsive Arthroscopy Wedge Push-In Suture Anchors (January 18, 2019)
  • K180951 — Responsive Arthroscopy Suture Anchor System (January 3, 2019)

Other clearances for product code MBI

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  • K253693 — Strut Suture; No-Tie Button (March 11, 2026)
  • K260405 — FiberTape Button (March 9, 2026)
  • K253538 — TeKBrace Knotless Anchor (March 6, 2026)
  • K254306 — Aevumed FENIX Suture Anchor (March 4, 2026)
  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253695 — LigaMend (February 27, 2026)
  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253618 — QuadLock™ Fixation System (January 6, 2026)