Class Class II
ONVOY™ Acetabular System (K243456)
Description
ONVOY™ Acetabular System by Globus Medical, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243456
Clearance Date2025-06-06
Clearance TypeTraditional
Product CodeLPH
Regulation Number888.3358
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243456
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. ONVOY™ Acetabular System (K243456) cites 8 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213842 | ONVOY Acetabular System | Globus Medical, Inc. | 2022 |
| K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethyl... | Zimmer, Inc. | 2019 |
| K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2019 |
| K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular In... | Howmedica Osteonics Corp. A.K.A. St... | 2019 |
| K161190 | G7 Dual Mobility System, Active Articulation System | Biomet, Inc. | 2016 |
| K150522 | G7 Dual Mobility System | Biomet, Inc. | 2015 |
| K094035 | EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343... | Stelkast Company | 2011 |
| K103233 | MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT | Howmedica Osteonics Corp. | 2011 |
Trace the full predicate network for K243456
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.