Class Class II
GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor (K243790)
Description
GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor by Depuy Mitek, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243790
Clearance Date2025-02-05
Clearance TypeTraditional
Product CodeMAI
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243790
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. GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor (K243790) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181809 | GRYPHON® Anchors with DYNACORD™ Suture | Medos International SARL | 2018 |
| K141259 | GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH... | Depuy Mitek, A Johnson & Johnson Co... | 2014 |
| K103712 | GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/... | Depuy Mitek, A Johnson & Johnson Co... | 2011 |
| K102298 | TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORT... | Depuy Mitek, A Johnson & Johnson Co... | 2011 |
| K090124 | GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/OR... | Depuy Mitek, A Johnson & Johnson Co... | 2009 |
| K073412 | GRYPHON BR AND HEALIX BR ANCHORS | Depuy Mitek, A Johnson & Johnson Co... | 2008 |
Trace the full predicate network for K243790
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.