Precision AI Surgical Planning System (PAI-SPS)

FDA 510(k) K251558 · Precision AI Pty, Ltd.

Substantially Equivalent

510(k) numberK251558

Submission

Device name
Precision AI Surgical Planning System (PAI-SPS)
Applicant
Precision AI Pty, Ltd.
Fortitude Valley, AU
Received
May 21, 2025
Decision date
January 12, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QHE – Shoulder Arthroplasty Implantation System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3660
Specialty
Orthopedic

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.

Other 510(k)s with product code QHE

510(k)DeviceApplicantDecision
K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Traditional Materialise NV06/09/2026SE
K261510Signature™ ONE SystemQHE · Special Orthosoft Inc. (d/b/a) Zimmer CAS06/04/2026SE
K260104Signature™ ONE SystemQHE · Special Orthosoft Inc. (d/b/a) Zimmer CAS02/04/2026SE
K243509Archer PSI SystemQHE · Traditional 3D-Side05/12/2025SE
K241470CORE Shoulder SystemQHE · Traditional LinkBio Corp.02/20/2025SE
K243955Precision AI Surgical Planning System (PAI-SPS)QHE · Special Precision AI Pty, Ltd.01/21/2025SE
K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special Materialise NV10/18/2024SE
K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareQHE · Traditional Arthrex, Inc.10/02/2024SE
K233992Precision AI Surgical Planning System (PAI-SPS)QHE · Traditional Precision AI Pty, Ltd.08/05/2024SE
K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special Materialise NV05/22/2024SE

More from Materialise NV

510(k)DeviceDecision
K243955Precision AI Surgical Planning System (PAI-SPS)QHE · Special 01/21/2025SE
K233992Precision AI Surgical Planning System (PAI-SPS)QHE · Traditional 08/05/2024SE

Questions and answers

When was Precision AI Surgical Planning System (PAI-SPS) cleared by the FDA?

Precision AI Surgical Planning System (PAI-SPS) (K251558) received a 510(k) decision of Substantially Equivalent on January 12, 2026, 236 days after the submission was received.

What is the product code of K251558?

The FDA product code is QHE – Shoulder Arthroplasty Implantation System, a Class II (moderate risk) device regulated under 21 CFR 888.3660.