510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251558Substantially Equivalent

Precision AI Surgical Planning System (PAI-SPS)

Precision AI Pty Ltd, Fortitude Valley, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251558 is the FDA 510(k) clearance record for Precision AI Surgical Planning System (PAI-SPS), a class II device, cleared for Precision AI Pty, Ltd. on under FDA product code QHE (Shoulder Arthroplasty Implantation System). FDA's definition for product code QHE reads: "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...". FDA records list 3 510(k) clearances for Precision AI Pty, Ltd., from to . As of , FDA records show no recalls naming K251558.

Clearance record

Decision date
Received
(236 days to decision)
Product code
QHE Shoulder Arthroplasty Implantation System
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Applicant
Precision AI Pty, Ltd. Suite 18, 36 Agnes St., Fortitude Valley, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QHE

Trailing 12 months
4 clearances under product code QHE in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QHE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260