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ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM - Extraction Tool

by Arthrocare Corp.

510(k) K102262

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 · Traditional NumberK102262 Date21 Oct 2010ClearedStatusActive

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  • Withdrawn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
Models / Variants
Extraction Tool
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Arthrocare Spartan PEEK Suture Implant System is a fully-threaded, corkscrew-shaped bone anchor made of polyether-etherketone (PEEK) with a 5.5mm diameter. It is preconfigured with MagnumWire sutures for knot tying and mounted on a disposable delivery driver. The system includes associated instruments such as a punch tap and extraction tool for implantation and removal.

The device is used to secure soft tissue to bone during orthopedic procedures. It is supplied as a sterile, single-use system. The device has received FDA 510(k) clearance under K102262 and is classified as FDA Class 2.

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Questions

AI-generated answers, 6 Oct 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 Arthrocare Spartan PEEK Suture Implant System used for?

    The Arthrocare Spartan PEEK Suture Implant System is used to secure soft tissue to bone during orthopedic procedures, providing fixation through its fully-threaded, corkscrew-shaped PEEK design with preattached MagnumWire sutures for knot tying.

  • How is the Arthrocare Spartan PEEK Suture Implant System supplied and is it reusable?

    The Arthrocare Spartan PEEK Suture Implant System is supplied as a sterile, single-use system, meaning each unit is intended for one procedure only and must be discarded after use to maintain sterility and prevent cross-contamination.

  • What components are included in the Arthrocare Spartan PEEK Suture Implant System?

    The system includes a fully-threaded, corkscrew-shaped PEEK bone anchor with a 5.5mm diameter, preconfigured with MagnumWire sutures for knot tying, mounted on a disposable delivery driver, along with associated instruments: a punch tap for preparing the bone site and an extraction tool for removal if needed.

  • What is the diameter of the bone anchor in the Arthrocare Spartan PEEK Suture Implant System?

    The bone anchor in the Arthrocare Spartan PEEK Suture Implant System has a diameter of 5.5mm, as specified in the device description, which determines the size of the bone tunnel required for implantation.

  • What material is the bone anchor made of in the Arthrocare Spartan PEEK Suture Implant System?

    The bone anchor in the Arthrocare Spartan PEEK Suture Implant System is made of polyether-etherketone (PEEK), a radiolucent, biocompatible polymer commonly used in orthopedic implants due to its mechanical properties and compatibility with imaging.