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OrthoButton AL

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171060

by Riverpoint Medical

Identifiers

510(k) Number
K171060 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)

OrthoButton AL is a suture retention device used for bone and soft tissue fixation during ligament or tendon reconstruction. It consists of a braided ultra-high molecular weight polyethylene (UHMWPE) adjustable loop and a button component designed to secure sutures to bone.

The device is supplied sterile and intended for single-use in orthopedic surgical settings. It is authorized under FDA 510(k) clearance (K171060) and classified under product code MBI with advisory committee designation OR (Orthopedic).

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: OrthoButton AL (K230212) — FDA 510 (k) | Innolitics, OrthoButton AL (K171060) — FDA 510 (k) | Innolitics, Riverpoint Medical Sports Medicine Suture and Tape Portfolio

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Riverpoint Medical

Sources (1)

  • FDA 510(k) K171060 24 fields · synced Oct 1, 2026