Devices · Precision AI Pty Ltd

Precision AI Surgical Planning System (PAI-SPS)

Precision AI Pty Ltd is listed for Precision AI Surgical Planning System (PAI-SPS) (K233992). The FDA list gives August 5, 2024 as the date of the final decision. The lead panel is Orthopedic, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QHE as “Shoulder Arthroplasty Implantation System”: Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233992

Official FDA database record

Date of final decision

August 5, 2024

Company on the FDA list

Precision AI Pty Ltd

Lead panel

Orthopedic

Primary product code

QHE

openFDA device name for the code

Shoulder Arthroplasty Implantation System

Device class

2

Regulation number

888.3660

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary