Orthopedic · 510(k) · 2025
Precision AI Surgical Planning System (PAI-SPS)
Precision AI Pty Ltd. Cleared by FDA on 21 January 2025 under submission K243955, product code QHE (shoulder arthroplasty implantation system). What FDA's record says, in FDA's words.
Device record · K243955
- Device. Precision AI Surgical Planning System (PAI-SPS)DEVICE
- Company. Precision AI Pty Ltd (AU)COMPANY
- Decision. 21 January 2025, 510(k), substantially equivalent (special review); received 23 December 2024DECISION
- Panel. OrthopedicPANEL
- Product code. QHE, Shoulder Arthroplasty Implantation SystemCODE
- Regulation. 21 CFR 888.3660, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Software 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. Hardware 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 […]
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 8 reports filed against devices carrying product code QHE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
7 July 2026 · Malfunction · ARTHREXVIP WEB PORTAL · ARTHREX, INC. · report 1220246-2026-03626
IT WAS REPORTED THAT DURING A UNVERS REVERSE SHOULDER ARTHROPLASTY THE SURGEON DISCOVERED A DISCREPANCY BETWEEN THE PDF HAND-OUT AND THE WEB-BASED VIP PLANNING SOFTWARE. HE NOTICED THAT HE HAD PLANNED A 100% BACKSIDE SEATING AND WHEN HE OPENED THE PDF DURING THE SURGERY, HE REALIZED THAT THERE WAS SOMETHING DIFFERENT. HE DISCOVERED THAT THE STEM WAS DIFFERENT, THE SCREW LENGTHS WERE MISSING AND THE MARKING FOR THE AUGMENTED BASEPLATE HAD DISAPPEARED. AT THIS TIME, THE PATIENT WAS ALREADY UNDER […]
6 March 2026 · Malfunction · CORE SHOULDER SYSTEM · LINKBIO CORP. · report 3006721341-2026-00004
TWO CORE WORKSTATIONS IN INVENTORY WERE FOUND TO HAVE OUT-OF-SYNC TIME/DATE. AN ENGINEER LOGGED INTO THE SERVICE ACCOUNT FOR EACH WORKSTATION TO VIEW THE TIME AND DATE DISPLAYED ON THE TABLET'S CLOCK AND THEY WERE OBSERVED TO BE OUT-OF-SYNC BY SEVERAL MONTHS. AN ENGINEER THEN RE-SYNCED THESE WORKSTATIONS.
15 January 2025 · Malfunction · BLUEPRINT SOFTWARE · WRIGHT MEDICAL TECHNOLOGY INC · report 3000931034-2025-00037
AS REPORTED: "DR. (B)(6) IS GETTING AN ERROR WHEN HE TRIES TO LOAD THIS CASE. THE PATIENT WAS SUPPOSED TO HAVE SURGERY TODAY BUT HAS BEEN POSTPONED SINCE THEY CAN'T GET BP TO WORK.".
8 April 2024 · Malfunction · BLUEPRINT SOFTWARE · TORNIER S.A.S. · report 3000931034-2024-00196
AS REPORTED: "BLUEPRINT SOFTWARE ALLOWED USERS TO PLAN SURGERIES USING INCOMPATIBLE (NOT APPROVED) CONFIGURATIONS."
8 April 2024 · Malfunction · BLUEPRINT SOFTWARE · TORNIER S.A.S. · report 3000931034-2024-00198
AS REPORTED: "BLUEPRINT SOFTWARE ALLOWED USERS TO PLAN SURGERIES USING INCOMPATIBLE (NOT APPROVED) CONFIGURATIONS".
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QHE, in Orthopedic, from Precision AI Pty Ltd, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.