510(k) · Cleared
ClearedVeritas Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restor3D · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jul 1, 2026 as substantially equivalent to K193099 (Zimmer GmbH, 2020) after a 132-day review. Its family tree reaches back 14 generations to 1991. 1 of the 73 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 1, 2026
- Review
- 132 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K911686 (1991). 72 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 73 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK113121 Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
- 2 generations backK170711 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical…Zimmer GmbH · 2017
- 1 generation backK193099 Anatomical Shoulder SystemZimmer GmbH · 2020
- This deviceK260556 Veritas Shoulder SystemRestor3D · 2026
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 3 generations backK113121 Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
- 2 generations backK170711 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical…Zimmer GmbH · 2017
- 1 generation backK193099 Anatomical Shoulder SystemZimmer GmbH · 2020
- This deviceK260556 Veritas Shoulder SystemRestor3D · 2026
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −7 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −6 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −5 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −4 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −3 | K113121 | Comprehensive Reverse Shoulder | Biomet Manufacturing, Inc. | 2011 | — |
| −2 | K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder… | Zimmer GmbH | 2017 | — |
| −1 | K193099 | Anatomical Shoulder System | Zimmer GmbH | 2020 | — |
| 0 (this device) | K260556 | Veritas Shoulder System | Restor3D | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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.
1 device in this family has a Class I recall. 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 PHX device
- #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 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 |
|---|---|---|---|
| * | K193099 | Anatomical Shoulder SystemSummary page 6…the following devices: 510{k) Trade Name Manufacturer Primary Predicate Device K193099 Anatomical Shoulder System Zimmer Biomet Reference Device… | 2020 |
| † | K243643 | restor3d Reverse Total Shoulder Arthroplasty System | 2025 |
| † | K203375 | OVOMotion Reverse Shoulder Arthroplasty System | 2021 |
| † | K162455 | Humelock Reversed Shoulder | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 24 of the 72 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, 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 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
Reverse Application of the Veritas Shoulder System: The Veritas Shoulder System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Veritas Reverse Total Shoulder System…
Read the full statement (190 words)
Reverse Application of the Veritas Shoulder System:
The Veritas Shoulder System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Veritas Reverse Total Shoulder System standard components are indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The Veritas system’s patient specific components are only indicated for primary total shoulder replacement.
Glenoid component with porous surface is indicated for uncemented application with the addition of screw fixation.
Note: A CT scan is used to create the Veritas patient specific components
Hemiarthroplasty Application of the Veritas Shoulder System:
The Veritas Shoulder System is indicated for:
Advanced wear and tear of the shoulder joint resulting from degenerative, post-traumatic, or rheumatoid arthritis if adequate bone stock is present.
Avascular Necrosis
Conditions consequent to earlier operations
Humeral components with porous surface are indicated for either cemented or uncemented applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260556: Veritas Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260556
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026