510(k) · Cleared
ClearedArcher PSI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D-Side · QHE Shoulder Arthroplasty Implantation System
Cleared on May 12, 2025 as substantially equivalent to K190738 (Medacta International S.A., 2019) after a 181-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- May 12, 2025
- Review
- 181 days
- Class
- Class II
- Product code
- QHE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K905070 (1991). 99 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 11 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 7 generations between
- 3 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 2 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 1 generation backK190738 MyShoulder Placement GuidesMedacta International S.A. · 2019
- This deviceK243509 Archer PSI System3D-Side · 2025
Show all 11 generations
- Root · 11 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 10 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 9 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 8 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 7 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 6 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 5 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 4 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 3 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 2 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 1 generation backK190738 MyShoulder Placement GuidesMedacta International S.A. · 2019
- This deviceK243509 Archer PSI System3D-Side · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −10 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −9 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −8 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −7 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −6 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −5 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −4 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −3 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −2 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −1 | K190738 | MyShoulder Placement Guides | Medacta International S.A. | 2019 | — |
| 0 (this device) | K243509 | Archer PSI System | 3D-Side | 2025 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K190738 | MyShoulder Placement GuidesSummary page 5…Shoulder Prosthesis, Reverse Configuration Device Trade Name MyShoulder™ Placement Guides 510(k) number K190738 Original Applicant Medacta International SA Regulation Number 21 CFR… | 2019 |
| † | K152825 | Catalyst CSR Shoulder System | 2016 |
| † | K173812 | Catalyst CSR 3 Peg Glenoids | 2018 |
| † | K181287 | Catalyst CSR Shoulder System | 2018 |
| † | K182500 | Catalyst CSR Press-Fit Humeral Components | 2019 |
| † | K191811 | Catalyst OrthoScience CSR Shoulder System | 2019 |
| † | K222317 | Catalyst EA Convertible Stemmed Shoulder | 2022 |
| † | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | 2021 |
| † | K211991 | Catalyst R1 Reverse Shoulder System | 2021 |
| † | K213349 | Catalyst R1 Reverse Shoulder System | 2022 |
| † | K223655 | Catalyst R1 Reverse Shoulder System | 2023 |
| † | K232583 | Catalyst R1 Reverse Shoulder System | 2023 |
| † | K213779 | Customize | 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 34 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 19 of the 99 ancestors have a recall of any class.
- 1 other device also cites its predicate K190738.
How does its category compare?
All QHE devicesQHE Shoulder Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
ArcherR PSI System is indicated as an orthopedic instrument to assist the physician in the intra-operative positioning of total shoulder replacement components and in guiding the drill and the cut of the bone. ArcherR PSI System must only be used conjointly with Archer ™ CSR Total Shoulder (K152825, K173812, K181287, K182500, K191811), Catalyst EA Convertible Stemmed Shoulder (K222317) and Archer ™ R1 Reverse (K202611, K211991, K213349, K223655, K232583)…
Read the full statement (183 words)
ArcherR PSI System is indicated as an orthopedic instrument to assist the physician in the intra-operative positioning of total shoulder replacement components and in guiding the drill and the cut of the bone.
ArcherR PSI System must only be used conjointly with Archer ™ CSR Total Shoulder (K152825, K173812, K181287, K182500, K191811), Catalyst EA Convertible Stemmed Shoulder (K222317) and Archer ™ R1 Reverse (K202611, K211991, K213349, K223655, K232583) components in the context of primary total shoulder replacement and following a delto-pectoral approach only. ArcherR PSI System is manufactured from a pre-operative planning validated by the surgeon in the 'Archer ™ 3D Targeting' platform (K213779). ArcherR PS I System is indicated for patient population fulfilling the Archer ™ CSR Total Shoulder, Catalyst EA Convertible Stemmed Shoulder and Archer ™ R1 Reverse indications and for which CT images are available with identifiable placement anatomical landmarks and compliant with imaging protocol provided by Archer 3D Targeting.
The device is intended for single use only.
The device is intended for adult patients.
The device has to be used by a physician trained in the performance of surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243509: Archer PSI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243509
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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