Class Class II
Stitch Cerclage – Suture Tapes (K243905)
Description
Stitch Cerclage – Suture Tapes by GM Dos Reis Industria e Comercio Ltda., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243905
Clearance Date2025-08-14
Clearance TypeTraditional
Product CodeJDQ
Regulation Number888.3010
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243905
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. Stitch Cerclage – Suture Tapes (K243905) cites 3 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 |
| K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2022 |
| K200332 | EXPERT - Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2020 |
Trace the full predicate network for K243905
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.