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5.5mm Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction Tool

by Arthrocare Corp.

510(k) K110164

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 NumberK110164 Date7 Feb 2011ClearedStatusActive

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  • Withdrawn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, 27 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 device is a fully-threaded, corkscrew-shaped bone anchor made of polyether-etherketone (PEEK) with a 5.5mm diameter. It is preconfigured with #2 Magnum Wire sutures and mounted on a disposable delivery driver for securing soft tissue to bone during orthopedic procedures.

The system includes associated instruments such as a punch tap and extraction tool for implantation and removal. It is used by surgeons in clinical or operating room settings for soft tissue-to-bone fixation. The device received FDA 510(k) clearance under k-number K110164 and is classified under product code MBI with special clearance type.

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Questions

AI-generated answers, 27 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 5.5MM SPARTAN PEEK SUTURE IMPLANT used for?

    The device is used by surgeons to secure soft tissue to bone during orthopedic procedures, functioning as a fully-threaded, corkscrew-shaped bone anchor made of PEEK with preattached #2 Magnum Wire sutures for reliable fixation.

  • What components are included with the 5.5MM SPARTAN PEEK SUTURE IMPLANT system?

    The system includes the 5.5mm PEEK suture implant preconfigured with #2 Magnum Wire sutures, mounted on a disposable delivery driver, along with associated instruments: a punch tap for site preparation and an extraction tool for potential removal.

  • Is the 5.5MM SPARTAN PEEK SUTURE IMPLANT sterile and intended for single use?

    Yes, the implant is supplied sterile and mounted on a disposable delivery driver, indicating it is designed for single-use application in clinical or operating room settings to maintain sterility and prevent cross-contamination.