Class Class II
GMK Sphere & GMK SpheriKA Cementless (K223548)
Description
GMK Sphere & GMK SpheriKA Cementless by Medacta International S.A., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223548
Clearance Date2023-01-20
Clearance TypeTraditional
Product CodeMBH
Regulation Number888.3565
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223548
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. GMK Sphere & GMK SpheriKA Cementless (K223548) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211004 | GMK Spherika Femurs and Fixed Tibial Trays Plus | Medacta International S.A. | 2021 |
| K140826 | GMK SPHERE EXTENSION | Medacta International | 2014 |
| K121416 | GMK SPHERE | Medacta International | 2012 |
| K113550 | VANGUARD COMPLETE KNEE SYSTEM | Biomet Manufacturing Corp | 2012 |
| K091543 | LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS | Smith & Nephew, Inc. | 2009 |
Trace the full predicate network for K223548
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.