Cleared Special

K243955 - Precision AI Surgical Planning System (PAI-SPS) (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243955 · Precision AI Pty, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
29d
Days
Class 2
Risk

K243955 is an FDA 510(k) clearance for the Precision AI Surgical Planning System (PAI-SPS). Classified as Shoulder Arthroplasty Implantation System (product code QHE), Class II - Special Controls.

Submitted by Precision AI Pty, Ltd. (Fortitude Valley, AU). The FDA issued a Cleared decision on January 21, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Precision AI Pty, Ltd. devices

Submission Details

510(k) Number K243955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2024
Decision Date January 21, 2025
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QHE Shoulder Arthroplasty Implantation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition 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 this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - QHE Shoulder Arthroplasty Implantation System

All 23
Devices cleared under the same product code (QHE) and FDA review panel - the closest regulatory comparables to K243955.
Signature™ ONE System
K260104 · Orthosoft Inc. (d/b/a) Zimmer CAS · Feb 2026
Precision AI Surgical Planning System (PAI-SPS)
K251558 · Precision AI Pty, Ltd. · Jan 2026
Archer PSI System
K243509 · 3D-Side · May 2025
CORE Shoulder System
K241470 · LinkBio Corp. · Feb 2025
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
K242813 · Materialise NV · Oct 2024
Arthrex Virtual Implant Positioning (VIP) System Software
K241097 · Arthrex, Inc. · Oct 2024