Home / 510(k) Clearances / K101184

510(k) K101184

TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 by Arthrocare Corp. — Product Code MBI

K101184 is an FDA 510(k) premarket notification submitted by Arthrocare Corp. for the device "TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006". The FDA issued a decision of Substantially Equivalent on May 18, 2010. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Arthrocare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2010
Date Received
April 28, 2010
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 Arthrocare Corp.

  • K153186 — Adjustable Fixation Device (January 28, 2016)
  • K131709 — SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT (October 4, 2013)
  • K130196 — SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR (February 27, 2013)
  • K111399 — SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURA (July 20, 2011)
  • K111397 — TITAN TI SUTURE ANCHOR SYSTEM (July 12, 2011)
  • K110781 — 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTR (May 27, 2011)
  • K110183 — ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE (February 16, 2011)
  • K110164 — 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL (February 7, 2011)
  • K101437 — SPEEDFIX SUTURE SYSTEM (October 29, 2010)
  • K102262 — ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL (October 21, 2010)

Other clearances for product code MBI

  • K261869 — Integrity Retractable Implant Inserter (6000127) (September 17, 2026)
  • K253065 — Aevumed SUPERCYNCH™ Button System (September 2, 2026)
  • K262809 — ArthroTAK Tendon Anchor Kit (September 2, 2026)
  • K262677 — Iconix Knotless T (August 27, 2026)
  • K262047 — Grappler Suture Anchor System (August 3, 2026)
  • K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repai (July 30, 2026)
  • K261770 — Suture Button Repair System (July 29, 2026)
  • K261632 — Thunderbolt System (July 20, 2026)
  • K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MI (July 9, 2026)
  • K260018 — Arthrex FiberButton (June 26, 2026)

FDA data resources