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APPIANFX Suture Anchor (6MM) (5MM) APPIANFX Tissue Anchor

by Kfx Medical

510(k) K120841

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK120841 Date7 Jun 2012ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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 APPIANFX Suture Anchor (6mm) (5mm) APPIANFX Tissue Anchor is an orthopedic fixation device for soft tissue-to-bone attachment. It comprises a PEEK body with deployable legs, a wedge (cleated for tissue anchors), and a preloaded suture loop (suture anchors only) housed in a disposable delivery handle.

The device is supplied sterile and is intended for single-use. It is classified as a Class II medical device under product code MBI and received FDA 510(k) clearance (K120841) on June 7, 2012, with a determination of substantial equivalence.

Other devices from Kfx Medical

Questions

AI-generated answers, 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.

  • What is the APPIANFX Suture Anchor used for?

    The APPIANFX Suture Anchor is an orthopedic fixation device designed for soft tissue-to-bone attachment. It consists of a PEEK body with deployable legs, a wedge with cleats for tissue anchors, and a preloaded suture loop in a disposable delivery handle.

  • How is the APPIANFX Suture Anchor supplied?

    The device is supplied sterile and is intended for single-use. It comes in two sizes: 6mm and 5mm, and includes a disposable delivery handle for proper application.

  • What is the regulatory status of the APPIANFX Suture Anchor?

    The APPIANFX Suture Anchor is classified as a Class II medical device under product code MBI. It received FDA 510(k) clearance (K120841) on June 7, 2012, with a determination of substantial equivalence.

  • Can the APPIANFX Suture Anchor be reused?

    No, the APPIANFX Suture Anchor is intended for single-use only. It is supplied sterile and should not be reused for patient safety and regulatory compliance reasons.