# K200332: EXPERT - Joint Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Oct 29, 2020 after 262 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: 11 generations back to K792022 (1979). 59 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090107: Mini Tightrope, Arthrex, Inc. (2009) Summary page 4.
- K061925: Mini Tightrope Repair Kit, Model AR-8911DS, Arthrex, Inc. (2006) Summary page 4.
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 4.
- K111032: CMC Cable Fix, Instratek, Inc. (2011) Summary page 4.

## Most influential descendants
- K242311: EXPERT - Flexible Joint Fixation System (2024), 0 descendants of its own

## Indications for use
The EXPERT - 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 Mini EXPERT, EXPERT Knotless and EXPERT Knotless Dual are intended to provide fixation during the healing process following: Mini EXPERT When used for fixation of bone-to-bone, the Mini EXPERT is intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair, such as: - Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions; - Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and - Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis. EXPERT Knotless and EXPERT Knotless Dual Syndesmotic trauma, such as fixation ofsyndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Source page: https://510kreport.com/device/K200332
Methodology: https://510kreport.com/methodology