Cleared Traditional

K251558 - Precision AI Surgical Planning System (PAI-SPS) (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251558 · Precision AI Pty, Ltd. · Orthopedic device
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Jan 2026
Decision
236d
Days
Class 2
Risk

K251558 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 12, 2026 after a review of 236 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate-to-high equivalence dependency. 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 K251558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2025
Decision Date January 12, 2026
Days to Decision 236 days
Submission Type Traditional
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
114d slower than avg
Panel avg: 122d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Stefanie Michele Auf Der Mauer Asmuss
Stefanie Auf der Mauer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K251558.
Signature™ ONE System
K260104 · Orthosoft Inc. (d/b/a) Zimmer CAS · Feb 2026
Archer PSI System
K243509 · 3D-Side · May 2025
CORE Shoulder System
K241470 · LinkBio Corp. · Feb 2025
Precision AI Surgical Planning System (PAI-SPS)
K243955 · Precision AI Pty, Ltd. · Jan 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