Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031914485

FEI Number

3031914485

Entity Name

PRECISION AI PTY LTD

City/State/Country

Brisbane Queensland, AU

Establishment Address

Suite 18, 36 Agnes Street, Fortitude Valley, Brisbane Queensland 4006, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Precision AI Pty Ltd (Owner Number: 10091281)

Owner / Operator Contact Address

Suite 18, 36 Agnes Street, Fortitude Valley, Brisbane, AU-QLD 4006, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233992

PMA Number

N/A

All Registered Proprietary Names

Precision AI Surgical Planning System (PAI-SPS) Precision AI Surgical Planning System (PAI-SPS)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-09-11
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-09-11
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2025-09-11
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2024-08-11
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-08-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-08-11

Official Correspondent

Daniel Ward

US Agent Details

Sherri Mellingen Business: Encore Medical Email: Sherri.Mellingen@enovis.com Phone: (512) 8329500

Related Public Records

Same Entity

Precision AI Pty Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031914485. Last updated year: 2026. Please use registration number 3031914485 when referencing this establishment in official correspondence.