# K251558: Precision AI Surgical Planning System (PAI-SPS)

- Pathway: 510(k) (Traditional)
- Applicant: Precision AI Pty, Ltd.
- Decided: Jan 12, 2026 after 236 days
- Product code: QHE (Shoulder Arthroplasty Implantation System)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K905070 (1991). 109 ancestors in all.
No later device cites it as a predicate yet.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243955: Precision AI Surgical Planning System (PAI-SPS), Precision AI Pty, Ltd. (2025) Summary page 7.
- K193560: Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner, Materialise NV (2020) Summary page 7.
- K242813: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, Materialise NV (2024) Summary page 7.

## Indications for use
The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels. The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection. The Precision AI Guides and Biomodels are indicated for single use only. The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only. The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components: Enovis: * AltiVate Anatomic (K162024, K173073, K193226 (CS Edge)) * AltiVate Anatomic Augmented (K213387, K222592) * Turon Shoulder System (K111629, K080402, K123982) * Reverse Shoulder Prosthesis (K051075, K092873, K1 11629, K100741, K1 11061, K1 11735, K041066, K141006) * AltiVate Reverse (K141990, K172351, K190290) * AltiVate Reverse Glenoid (ARG) (K233481) Lima: * SMR Shoulder System (K161476, K100858, K101263) * SMR Reverse Shoulder System (K1 10598) * SMR 40MM Glenosphere (K142139) * SMR 3-Pegs Glenoid (Ki153722, K130642) * SMR Modular Glenoid (K1 13254, K143256) * SMR TT Metal Back Glenoid (K133349) * SMR Hybrid Glenoid System (K163397) * SMR Stemless Anatomic (K221758) * SMR 1400 Reverse Humeral Body (K201905) * SMR TT Augmented Glenoid System (K191746, K200171) * SMR Lateralized Connectors with screws (K183042) * SMR TT Augmented 360 Baseplate (K220792) * SMR TT Hybrid Glenoid (K220792) * PRIMA Humeral System and SMR Glenosphere 042 (K212800) * PRIMA TT Glenoid (K222427)

Source page: https://510kreport.com/device/K251558
Methodology: https://510kreport.com/methodology