Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) (K243665)
Description
Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) by ZheJiang Decans Medical Devices Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243665
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. Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) (K243665) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Mode... | Smith & Nephew, Inc. | 2015 |
| K113294 | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR | Smith & Nephew, Inc. | 2012 |
| K101679 | ARTHREX PUSHLOCK ANCHORS | Arthrex, Inc. | 2010 |
| K063479 | ARTHREX PUSHLOCK | Arthrex, Inc. | 2006 |
| K061665 | ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT | Arthrex, Inc. | 2006 |
Trace the full predicate network for K243665
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.