510(k) · Cleared
ClearedPrecision AI Surgical Planning System (PAI-SPS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision AI Pty, Ltd. · QHE Shoulder Arthroplasty Implantation System
Cleared on Jan 12, 2026 as substantially equivalent to K243955 (Precision AI Pty, Ltd., 2025) and 2 other predicates after a 236-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Jan 12, 2026
- Review
- 236 days
- Class
- Class II
- Product code
- QHE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K905070 (1991). 109 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 9 generations between
- 3 generations backK190738 MyShoulder Placement GuidesMedacta International S.A. · 2019
- 2 generations backK233992 Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2024
- 1 generation backK243955 Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2025
- This deviceK251558 Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2026
Show all 13 generations
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 12 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 11 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 10 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 9 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 8 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 7 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 6 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 5 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 4 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 3 generations backK190738 MyShoulder Placement GuidesMedacta International S.A. · 2019
- 2 generations backK233992 Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2024
- 1 generation backK243955 Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2025
- This deviceK251558 Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −12 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −11 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −10 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −9 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −8 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −7 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −6 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −5 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −4 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −3 | K190738 | MyShoulder Placement Guides | Medacta International S.A. | 2019 | — |
| −2 | K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2024 | — |
| −1 | K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2025 | — |
| 0 (this device) | K251558 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QHE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QHE device
- #1 K242813 Materialise Shoulder System™, Materialise…score 19.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243955 | Precision AI Surgical Planning System (PAI-SPS)Summary page 7…K251558 - Page 2 of 5 3 Predicate and Reference Devices Primary Predicate Device 510(k) Number: K243955 Device Trade Name: Precision AI Surgical Planning System (PAI-SPS) Submitter: Precision AI Pty Ltd… | 2025 |
| * | K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner…Summary page 7…ty Ltd Product Code(s): QHE - Shoulder Arthroplasty Implantation System KWS, PHX Predicate Device 510(k) Number: K193560, K242813 Device Trade Name: Materialise Shoulder System, SurgiCase Shoulder Planner Submitter: Materi… | 2020 |
| * | K242813 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Summary page 7…Product Code(s): QHE - Shoulder Arthroplasty Implantation System KWS, PHX Predicate Device 510(k) Number: K193560, K242813 Device Trade Name: Materialise Shoulder System, SurgiCase Shoulder Planner Submitter: Materialise N.V… | 2024 |
| † | K222405 | Smart SPACE Shoulder Planner and 3D Positioners | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 109 ancestors have a recall of any class.
How does its category compare?
All QHE devicesQHE Shoulder Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QHE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QHE
181in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QHE
No recall names QHE since 2007.
Adverse event reports per year · QHE
1in 2025
MAUDE reports naming product code QHE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 3 | 88 | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 3 | 149 | 0 | 0 |
| 2023 | 6 | 103 | 0 | 0 |
| 2024 | 4 | 97 | 0 | 5 |
| 2025 | 3 | 181 | 0 | 1 |
| 2026 | 4 | 59 | 0 | — |
What is it indicated for?
The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a…
Read the full statement (379 words)
The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels.
The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.
The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection.
The Precision AI Guides and Biomodels are indicated for single use only.
The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only.
The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components:
Enovis:
* AltiVate Anatomic (K162024, K173073, K193226 (CS Edge))
* AltiVate Anatomic Augmented (K213387, K222592)
* Turon Shoulder System (K111629, K080402, K123982)
* Reverse Shoulder Prosthesis (K051075, K092873, K1 11629, K100741, K1 11061, K1 11735, K041066, K141006)
* AltiVate Reverse (K141990, K172351, K190290)
* AltiVate Reverse Glenoid (ARG) (K233481)
Lima:
* SMR Shoulder System (K161476, K100858, K101263)
* SMR Reverse Shoulder System (K1 10598)
* SMR 40MM Glenosphere (K142139)
* SMR 3-Pegs Glenoid (Ki153722, K130642)
* SMR Modular Glenoid (K1 13254, K143256)
* SMR TT Metal Back Glenoid (K133349)
* SMR Hybrid Glenoid System (K163397)
* SMR Stemless Anatomic (K221758)
* SMR 1400 Reverse Humeral Body (K201905)
* SMR TT Augmented Glenoid System (K191746, K200171)
* SMR Lateralized Connectors with screws (K183042)
* SMR TT Augmented 360 Baseplate (K220792)
* SMR TT Hybrid Glenoid (K220792)
* PRIMA Humeral System and SMR Glenosphere 042 (K212800)
* PRIMA TT Glenoid (K222427)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251558: Precision AI Surgical Planning System (PAI-SPS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251558
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026