510(k) · Cleared
Recalled · Class II · 2019Zimmer 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 9, 2013 as substantially equivalent to K052906 (Zimmer, Inc., 2005) and 3 other predicates after a 58-day review. Its family tree reaches back 9 generations to 1991. It has been recalled 2 times.
- Decided
- May 9, 2013
- Review
- 58 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 9 generations to K911686 (1991). 30 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- 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 deviceK130661 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2013
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 deviceK130661 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2013
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) | K130661 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2013 | — |
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 |
| 2012 | 1 | 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? (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 |
|---|---|---|---|
| * | K052906 | Zimmer Trabecular Metal Reverse Shoulder SystemSummary page 4…3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. Orthopedics/87 Zimmer® Trabecular Metal™ Reverse Shoulder System. manufactured by Zimmer, K052906, cleared December 19.2005. Zimmer® Trabecular Metal™ Reverse Shoulder System, Sizes 8mm and 10mm, manufactured by Zimmer, K06070… | 2005 |
| * | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMSummary page 4…oulder System. manufactured by Zimmer, K052906, cleared December 19.2005. Zimmer® Trabecular Metal™ Reverse Shoulder System, Sizes 8mm and 10mm, manufactured by Zimmer, K060704, cleared May 19, 2006. Zimmer® Trabecular Metal™ Reverse Shoulder System, Base Plates and Humeral Stems, manufactured by Zimmer,… | 2006 |
| * | K121543 | Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsSummary page 4…d 10mm, manufactured by Zimmer, K060704, cleared May 19, 2006. Zimmer® Trabecular Metal™ Reverse Shoulder System, Base Plates and Humeral Stems, manufactured by Zimmer, K 121543, cleared October 11, 2012. Zimmer® Trabecular Metal™ Reverse Shoulder System, Non-Porous Humeral Stems, manufactured by Zimmer,… | 2012 |
| * | K122692 | Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsSummary page 4…Stems, manufactured by Zimmer, K 121543, cleared October 11, 2012. Zimmer® Trabecular Metal™ Reverse Shoulder System, Non-Porous Humeral Stems, manufactured by Zimmer, K 122692, cleared December 3, 2012. The Zimmer Trabecular Metal Reverse Shoulder System consists of conventional and reverse, semi- and n… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0299-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Dec 10, 2013 | Class II | Z-0609-2014 | Labeling mix-ups | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 8 of the 30 ancestors have a recall of any class.
- 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. 2013, 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 Zimmer Trabecular Metal Shoulder System is indicated for the following: Hemiarthroplasty/total 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 where…
Read the full statement (231 words)
The Zimmer Trabecular Metal Shoulder System is indicated for the following:
Hemiarthroplasty/total 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 where arthrodesis or resectional arthroplasty is not acceptable.
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.
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 humeral components are intended for either cemented or uncemented use. The reverse base plate is intended for uncemented use, and requires two screws for fixation. When used in a total shoulder application, the all-polyethylene glenoid components are intended for cemented use only. In the USA, the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.
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/K130661 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130661: 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/K130661
Report an extraction error
Are you the manufacturer?
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