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G-Force Peek Suture Anchor System

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K100630

Overview

The G-Force Peek Suture Anchor System is a hand-held device for attaching soft tissue to bone. It includes PEEK-OPTIMA anchors preloaded with polyethylene-based sutures and tapered needles. The system is classified as a Fastener, Fixation, Nondegradable, Soft Tissue device. It is used by surgeons in clinical settings to repair instability in various joints.

The G-Force Peek Suture Anchor System is a sterile, single-use device. It is supplied with preloaded sutures and needles. The system has FDA 510K clearance, classified as Class II with Special Controls, under the product code MBI. It is intended for use in attaching soft tissue to bone, and is available in a specific configuration, as identified by the k number K100630.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100630 Date11 Jun 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the G-Force Peek Suture Anchor System used for?

    The G-Force Peek Suture Anchor System is used by surgeons to repair instability in various joints by attaching soft tissue to bone.

  • Is the G-Force Peek Suture Anchor System sterile?

    Yes, the G-Force Peek Suture Anchor System is a sterile, single-use device, supplied with preloaded sutures and needles.

  • What type of material is used in the G-Force Peek Suture Anchor System?

    The system includes PEEK-OPTIMA anchors preloaded with polyethylene-based sutures and tapered needles.

  • What is the regulatory status of the G-Force Peek Suture Anchor System?

    The system has FDA 510K clearance, classified as Class II with Special Controls, under the product code MBI.