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AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213110

by Auxein Medical Private Limited

Identifiers

510(k) Number
K213110 FDA 510(k)
FDA Product Code
MBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AUXILOCK PEEK OPTIMA Screw-In Suture Anchor and AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor are orthopedic devices designed for the attachment of soft tissue to bone. These anchors are made from PEEK OPTIMA material and are intended for use in shoulder procedures, specifically rotator cuff repair and acromioclavicular separation.

The device is supplied as a screw-in suture anchor and is indicated for use with sutures or tapes in rotator cuff repair using the 'bridge' or 'knotless' technique. It is a single-use implantable device, sterilized and provided in a sterile condition for surgical implantation. The device received FDA 510(k) clearance (K213110) as substantially equivalent to a predicate device, with product code MBI and review by the Orthopedic advisory committee.

Frequently asked questions

What is the AUXILOCK PEEK OPTIMA Screw-In Suture Anchor used for?

The AUXILOCK PEEK OPTIMA Screw-In Suture Anchor is designed for attaching soft tissue to bone in shoulder procedures, specifically for rotator cuff repair using bridge or knotless techniques and for acromioclavicular separation, as indicated in the device description.

Is the AUXILOCK PEEK OPTIMA Screw-In Suture Anchor sterile and single-use?

Yes, the device is supplied in a sterile condition and is intended as a single-use implantable device, meaning it is sterilized prior to use and should not be reused after implantation to maintain sterility and structural integrity.

What material is the AUXILOCK PEEK OPTIMA Screw-In Screw-In Suture Anchor made from, and how is it implanted?

The anchor is made from PEEK OPTIMA material and is designed as a screw-in suture anchor, meaning it is inserted into bone by screwing it in place to secure sutures or tapes during soft tissue fixation procedures.

What regulatory pathway was used for the AUXILOCK PEEK OPTIMA Screw-In Suture Anchor?

The device received FDA 510(k) clearance (K213110) as substantially equivalent to a predicate device, with product code MBI and review by the Orthopedic advisory committee, indicating it followed the traditional 510(k) submission route.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Auxilock ® Rotador Peek Optima Screw-in Anchor - Auxein, Auxilock ® Peek Optima Screw-in Suture Anchor - Auxein: Pioneering ..., AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Auxein Medical Private Limited

Sources (1)

  • FDA 510(k) K213110 24 fields · synced Sep 21, 2026