Class Class II
EXPERT – Flexible Joint Fixation System (K242311)
Description
EXPERT - Flexible Joint Fixation System by GM Dos Reis Industria e Comercio Ltda., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242311
Clearance Date2024-11-01
Clearance TypeTraditional
Product CodeHTN
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242311
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. EXPERT – Flexible Joint Fixation System (K242311) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | Gm Dos Reis Industria E Comerico Ltda. | 2023 |
| K200332 | EXPERT - Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2020 |
| K100652 | ACL TIGHTROPE | Arthrex, Inc. | 2010 |
| K052776 | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLES... | Arthrex, Inc. | 2005 |
Trace the full predicate network for K242311
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.