Class Class II
Precision AI Surgical Planning System (PAI-SPS) (K243955)
Description
Precision AI Surgical Planning System (PAI-SPS) by Precision AI Pty, Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243955
Clearance Date2025-01-21
Clearance TypeSpecial
Product CodeQHE
Regulation Number888.3660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243955
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. Precision AI Surgical Planning System (PAI-SPS) (K243955) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2024 |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with Markers | Encore Medical L.P. | 2023 |
| K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022 |
| K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | Encore Medical L.P. | 2020 |
| K173073 | AltiVate Anatomic to Reverse Conversion Module | Encore Medical L.P. | 2017 |
Trace the full predicate network for K243955
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.