510(k) · Cleared
Recalled · Class II · 2017Zimmer 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 Dec 19, 2005 as substantially equivalent to K041873 (Tornier, 2004) and 3 other predicates after a 66-day review. Its family tree reaches back 6 generations to 1991. 1 of the 243 devices in its family, counting itself, has a Class I recall. 216 later devices descend from it. It has been recalled 12 times.
- Decided
- Dec 19, 2005
- Review
- 66 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 12
- Predicates
- 4
Its longest line of descent runs back 6 generations to K911686 (1991). 26 ancestors in all, the oldest K790987 (1979). 216 later devices descend from it, 13 citing it directly. 1 of the 243 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 4 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 3 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 2 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 1 generation backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- This deviceK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005
- Descendant · cites it directly · 207 of its ownK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- Descendant · cites it directly · 190 of its ownK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 177 of its ownK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- Descendant · cites it directly · 175 of its ownK072804 Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007
- Descendant · cites it directly · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
Showing 5 of 216 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shouldercites it directly · 2008
Most influential descendants
Showing 5 of 216 · See all- K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · cites it directly207descendants
- K063569Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · cites it directly190descendants
- K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc. · 2008 · 2 generations on177descendants
- K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007 · cites it directly175descendants
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · cites it directly172descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −5 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −2 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −1 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| 0 (this device) | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | — |
| +1 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| +1 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| +2 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| +1 | K072804 | Comprehensive RS Shoulder System | Biomet Manufacturing Corp | 2007 | — |
| +1 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
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 |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 1 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 14 | 0 |
| 2018 | 12 | 0 |
| 2019 | 14 | 0 |
| 2020 | 18 | 0 |
| 2021 | 21 | 0 |
| 2022 | 17 | 0 |
| 2023 | 14 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 18 | 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? (4)
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 |
|---|---|---|---|
| * | K041873 | Aequalis Reversed Shoulder ProsthesisSummary page 1…888.3660, 888.3690 and 888.3650 Predicate Devices: Aequalis Reversed Shoulder Prosthesis, manufactured by Tornier, K041873, cleared August 25, 2004. Delta Shoulder, manufactured… | 2004 |
| * | K021478 | Delta ShoulderSummary page 1…nufactured by Tornier, K041873, cleared August 25, 2004. Delta Shoulder, manufactured by DePuy, K021478, cleared November 18, 2003. Encore Reverse Shoulder Pr… | 2003 |
| * | K041066 | Encore Reverse Shoulder ProsthesisSummary page 1…d November 18, 2003. Encore Reverse Shoulder Prosthesis, manufactured by Encore Medical, L.P., K041066, cleared March 24, 2005. Zimmer TrabecularMetal TM Hum… | 2005 |
| * | K041549 | Zimmer Trabecular Metal Humeral StemSummary page 1…24, 2005. Zimmer TrabecularMetal TM Humeral Stem, manufactured by Zimmer, Inc., K041549, cleared September 1,2004. Device Description: The Zimmer TrabecularMetal… | 2004 |
What descends from it? (216)
See all 21613 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | 2006 | 207 |
| K063569 | Equinoxe Reverse Shoulder System | 2007 | 190 |
| K072804 | Comprehensive RS Shoulder System | 2007 | 175 |
| K080642 | Comprehensive Reverse Shoulder Class I | 2008 | 172 |
| K122692 | Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral Stems | 2012 | 62 |
| K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small… | 2017 | 18 |
| K121543 | Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems | 2012 | 14 |
| K133378 | Zimmer Trabecular Metal Reverse Shoulder System | 2014 | 11 |
| K170748 | GLOBAL UNITE Platform Shoulder System | 2018 | 10 |
| K062029 | Anatomical Shoulder Fracture System | 2006 | 10 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2017 | Class II | Z-3144-2017 | Process control | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture. |
| Oct 17, 2013 | Class II | Z-1079-2014 | Device Design | As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the… |
| Aug 1, 2013 | Class II | Z-2055-2013 | Device Design | Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. As a result, there is a… |
| Sep 10, 2010 | Not classified | Z-0570-2011 | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant… |
| Sep 10, 2010 | Not classified | Z-0574-2011 | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant… |
| Sep 10, 2010 | Not classified | Z-0575-2011 | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant… |
| Sep 10, 2010 | Not classified | Z-0571-2011 | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant… |
| Sep 10, 2010 | Not classified | Z-0573-2011 | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant… |
| Sep 10, 2010 | Not classified | Z-0576-2011 | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant… |
| Jul 20, 2006 | Not classified | Z-1416-06 | Other | Components may not lock together as intended. |
| Jul 20, 2006 | Not classified | Z-1418-06 | Other | Components may not lock together as intended. |
| Jul 20, 2006 | Not classified | Z-1417-06 | Other | Components may not lock together as intended. |
The 5 latest of 12 recalls; the web page lists all.
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 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 26 ancestors have a recall of any class.
- Of its descendants, K060704 (Zimmer, Inc., 2006) has gone furthest, with 207 descendants of its own.
- 12 other devices also cite its predicate K041873.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following: Reverse application: 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…
Read the full statement (187 words)
The Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following:
Reverse application:
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.
Hemiarthroplast/Totalapplication:
- 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 where arthrodesis or resectional arthroplasty is not acceptable.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications).
The TrabecularMetal humeral and reverse base plate components are intended for either cemented or uncemented use. The reverse base plate requires two screws for initial fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052906: Zimmer Trabecular Metal Reverse Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052906
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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