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ICONN Answer Suture Anchor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132724

by Iconn Orthopedics, Llc

Identifiers

510(k) Number
K132724 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 ICONN Answer Suture Anchor is a suture anchor (Product Code: MBI) designed for soft tissue reattachment to bone. It is classified under orthopedic devices and intended for securing tendons, ligaments, or other soft tissues during surgical procedures, such as rotator cuff repair or foot/ankle surgeries. Constructed from PEEK (polyetheretherketone), it provides a biocompatible and rigid fixation point for stable tissue integration.

This device is supplied sterile and intended for single-use in clinical settings, including hospitals and surgery centers. It is regulated under FDA 510(k) clearance (K132724) and falls under the Orthopedic (OR) advisory committee classification. The anchor is available in specific sizes, including the 6.5 mm variant, and must be stored according to manufacturer guidelines to maintain sterility and performance.

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: ICONN Answer II PEEK Suture Anchor | Rotator Cuff Repair Anchor, ICONN Orthopedics | Value-Driven Orthopedic Implants, ICONN Answer II Suture Anchor (K181680) — FDA 510 (k) | Innolitics, ICONN Answer II Suture Anchor (K181680) - FDA 510 (k), ICONN Answer II 6.5MM Suture Anchor — FDA Class II Medical Device ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Iconn Orthopedics, Llc

Sources (1)

  • FDA 510(k) K132724 24 fields · synced Sep 19, 2026