Class Class II
Mako Shoulder Application (1.0) (K242373)
Description
Mako Shoulder Application (1.0) by Mako Surgical Corp., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242373
Clearance Date2024-11-07
Clearance TypeTraditional
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242373
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. Mako Shoulder Application (1.0) (K242373) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning S... | Blue Ortho | 2022 |
| K193128 | Mako Total Hip Application | Mako Surgical Corp. | 2020 |
| K172301 | Mako Partial Knee Application | Mako Surgical Corp. | 2017 |
Trace the full predicate network for K242373
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.