4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K142574 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• OmniSpan Meniscal Repair SYSTEM/0 Degree, Model 228140, RapidLoc A2 Meniscal Repair SYSTEM/12 Degree, Model 228141

  Class II

  FDA 510(k) K092836 Active Cleared 4 Feb 2010

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• Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809

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  FDA 510(k) K103831 Active Cleared 21 Jul 2011

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• Super Quickanchor Plus (with Orthocord Suture)

  Class II

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See all devices from Depuy Mitek, A Johnson & Johnson Company →

• What is the Healix Ti Anchor used for?

  The Healix Ti Anchor is designed for securing soft tissue to bone in orthopedic applications, such as rotator cuff or labral repairs, where titanium anchors with integrated suture strands provide stable fixation.

• How is the Healix Ti Anchor supplied and is it reusable?

  The device is supplied sterile and intended for single-use only; it must not be reprocessed or reused due to risks of contamination, material degradation, or compromised mechanical integrity after initial implantation.

• What sizes and suture configurations are available for the Healix Ti Anchor?

  The anchor is available in three diameters: 4.5mm, 5.5mm, and 6.5mm, each offered with either 2 or 3 strands of #2 Permacord suture pre-attached to the anchor, allowing flexibility based on tissue quality and surgical technique.

• What regulatory pathway was used for the Healix Ti Anchor?

  The device received FDA 510(k) clearance (K142574) as substantially equivalent to a predicate device, with product code MBI and review by the Orthopedic advisory committee, confirming its safety and effectiveness for the intended use.