510(k) · Cleared
ClearedZimmer Trabecular Metal Reverse Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on May 12, 2014 as substantially equivalent to K052906 (Zimmer, Inc., 2005) and 1 other predicate after a 189-day review. Its family tree reaches back 9 generations to 1991. 11 later devices descend from it.
- Decided
- May 12, 2014
- Review
- 189 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K911686 (1991). 29 ancestors in all, the oldest K790987 (1979). 11 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations between
- 3 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 2 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 1 generation backK121543 Zimmer Trabecular Metal Reverse Shoulder System, Base Plates &…Zimmer, Inc. · 2012
- This deviceK133378 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2014
- Descendant · cites it directly · 10 of its ownK181611 Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp · 2018
- Descendant · 2 generations on · 3 of its ownK210533 Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK200368 LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
- Descendant · 3 generations on · 1 of its ownK252221 Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK240876 Identity Shoulder SystemZimmer, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 6 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 5 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 4 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 3 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 2 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 1 generation backK121543 Zimmer Trabecular Metal Reverse Shoulder System, Base Plates &…Zimmer, Inc. · 2012
- This deviceK133378 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp · 2018 · cites it directly10descendants
- K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2021 · 2 generations on3descendants
- K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021 · 2 generations on3descendants
- K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2025 · 3 generations on1descendant
- K240876Identity Shoulder SystemZimmer, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −8 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −5 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −4 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −3 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −2 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −1 | K121543 | Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems | Zimmer, Inc. | 2012 | — |
| 0 (this device) | K133378 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2014 | — |
| +1 | K181611 | Comprehensive Reverse Shoulder System | Biomet Manufacturing Corp | 2018 | — |
| +2 | K210533 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2021 | — |
| +2 | K200368 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021 | — |
| +3 | K252221 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2025 | — |
| +2 | K240876 | Identity Shoulder System | Zimmer, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 PHX? 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? (2)
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 |
|---|---|---|---|
| * | K052906 | Zimmer Trabecular Metal Reverse Shoulder SystemSummary page 4…ditive, cemented prosthesis (PAO) (21 CFR 888.3660, 888.3690. 888.3650) Orthopedics/87 Zimmer® Trabecular Metal™ Reverse Shoulder System, manufactured by Zimmer. Inc., K052906. cleared December 19, 2005, and K121543, cleared October 11, 2012. The Zimmer Trabecular Metal Reverse Shoulder System Vivacit-E… | 2005 |
| * | K121543 | Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsSummary page 4…R 888.3660, 888.3690. 888.3650) Orthopedics/87 Zimmer® Trabecular Metal™ Reverse Shoulder System, manufactured by Zimmer. Inc., K052906. cleared December 19, 2005, and K121543, cleared October 11, 2012. The Zimmer Trabecular Metal Reverse Shoulder System Vivacit-E Vitamin E Highly Crosslinked Polyethyle… | 2012 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181611 | Comprehensive Reverse Shoulder System | 2018 | 10 |
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 23 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 29 ancestors have a recall of any class.
- Of its descendants, K181611 (Biomet Manufacturing Corp, 2018) has gone furthest, with 10 descendants of its own.
- 12 other devices also cite its predicate K052906.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The Trabecular Metal™ Reverse Shoulder System Vivacit-E™ Vitamin E Highly Crosslinked Polyethylene Liners are indicated for:
the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
ununited humeral head fractures of long duration;
irreducible 3-and 4-part proximal humeral fractures;
avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.
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/K133378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133378: Zimmer Trabecular Metal Reverse 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/K133378
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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