Skip to content

Self-Punching ICONIX

by Stryker 2 variants

510(k) K171465

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171465 Date24 Aug 2017ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Stryker Self-Punching ICONIX
510(k) Number
FDA product code
MBI
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Self-Punching ICONIX is an all-suture anchor system designed for orthopedic applications. It consists of a polyester sheath interwoven with non-absorbable working sutures, intended for precise fixation in rotator cuff repair procedures without the need for pre-drilling.

This device is supplied sterile and intended for single-use, featuring a disposable forked-tip inserter. The 2.3 mm anchor allows for multiple suture configurations, facilitating versatile repair techniques. Authorized under FDA 510(k) clearance (K171465), it adheres to traditional review standards for orthopedic devices.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →