Class Class II
Shoulder Soft Tissue Anchors (K242477)
Description
Shoulder Soft Tissue Anchors by Signature Orthopaedics Pty, Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242477
Clearance Date2025-05-12
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242477
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. Shoulder Soft Tissue Anchors (K242477) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173269 | KATOR Suture Anchor | Kator, LLC | 2018 |
| K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Mode... | Smith & Nephew, Inc. | 2015 |
| K113297 | KNOTILUS ANCHOR SYSTEM | T.A.G. Medical Products Corporation... | 2012 |
| K113294 | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR | Smith & Nephew, Inc. | 2012 |
Trace the full predicate network for K242477
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.