# K242311: EXPERT - Flexible Joint Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Nov 1, 2024 after 88 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K792022 (1979). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200332: EXPERT - Joint Fixation System, GM Dos Reis Industria e Comercio Ltda. (2020) Summary page 5.
- K100652: Acl Tightrope, Arthrex, Inc. (2010) Summary page 5.
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD, Arthrex, Inc. (2005) Summary page 5.

## Indications for use
The EXPERT - Flexible Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting. The EXPERT - Flexible Joint Fixation System are intended to provide fixation during the healing process following: EXPERT FAST - SYNDESMOSIS and EXPERT FAST DUAL: Syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures. EXPERT ACL and EXPERT ACL II: Fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, these models are offered for Anterior Cruciate Ligament (ACL) Repair. EXPERT FAST - CORACOID PLATE and EXPERT FAST- AC: Specifically, these models are intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

Source page: https://510kreport.com/device/K242311
Methodology: https://510kreport.com/methodology