510(k) · Cleared
Recalled · Class II · 2012Anatomical Shoulder Inverse/Reverse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jan 25, 2006 as substantially equivalent to K041873 (Tornier, 2004) and 3 other predicates after a 63-day review. Its family tree reaches back 6 generations to 1991. 1 of the 258 devices in its family, counting itself, has a Class I recall. 239 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 25, 2006
- Review
- 63 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 6 generations to K911686 (1991). 18 ancestors in all, the oldest K800494 (1980). 239 later devices descend from it, 13 citing it directly. 1 of the 258 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 deviceK053274 Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006
- Descendant · cites it directly · 190 of its ownK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- Descendant · cites it directly · 178 of its ownK071948 Aequalis Reversed AdapterTornier · 2007
- 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 · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 164 of its ownK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
Showing 5 of 239 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 239 · See all- K063569Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · cites it directly190descendants
- K071948Aequalis Reversed AdapterTornier · 2007 · cites it directly178descendants
- K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc. · 2008 · 2 generations on177descendants
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · cites it directly172descendants
- K082120Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008 · 2 generations on164descendants
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) | K053274 | Anatomical Shoulder Inverse/Reverse | Zimmer GmbH | 2006 | — |
| +1 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| +1 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| +2 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| +1 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| +2 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 5 | 1 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 12 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 15 | 0 |
| 2018 | 16 | 0 |
| 2019 | 15 | 0 |
| 2020 | 19 | 0 |
| 2021 | 23 | 0 |
| 2022 | 19 | 0 |
| 2023 | 15 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 19 | 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…cemented prosthesis (KWT) - 888.3650 Predicate Devices: · Tornier Aequalis Reversed Shoulder Prosthesis, K04 1873, cleared August 25, 2004 * DePuy Orthopaedics Delta Shoulder,… | 2004 |
| * | K021478 | Delta ShoulderSummary page 1…K04 1873, cleared August 25, 2004 * DePuy Orthopaedics Delta Shoulder, K021478, cleared November 18. 2003 * Encore Medical Encore Reverse Shoulder… | 2003 |
| * | K041066 | Encore Reverse Shoulder ProsthesisSummary page 1…K021478, cleared November 18. 2003 * Encore Medical Encore Reverse Shoulder Prosthesis, K041066, cleared March 24, 2005 * Centerpulse Orthopaedics Anatomical Shoulder… | 2005 |
| * | K030259 | Amatomical Shoulder with Removable HeadSummary page 1…ed March 24, 2005 * Centerpulse Orthopaedics Anatomical Shoulder System with Removable Heads, K030259. cleared April 24, 2003. Device Description: The Anatomical Shoulder Inv… | 2003 |
What descends from it? (239)
See all 23913 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063569 | Equinoxe Reverse Shoulder System | 2007 | 190 |
| K071948 | Aequalis Reversed Adapter | 2007 | 178 |
| K080642 | Comprehensive Reverse Shoulder Class I | 2008 | 172 |
| K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder System | 2008 | 52 |
| K110598 | SMR Reverse Shoulder System | 2011 | 44 |
| K150488 | Humelock II Reversible Shoulder System | 2015 | 30 |
| K130129 | Univers Revers Shoulder Prosthesis System | 2013 | 28 |
| K142863 | Univers Rivers Shoulder Prosthesis System | 2014 | 27 |
| K142139 | SMR 40MM Glenosphere | 2014 | 13 |
| K112193 | Arrow Reverse Shoulder System | 2012 | 10 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2012 | Class II | Z-0231-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
| Sep 4, 2012 | Class II | Z-0229-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
| Sep 4, 2012 | Class II | Z-0230-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product… |
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 15 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K063569 (Exactech, Inc., 2007) has gone furthest, with 190 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 Anatomical Shoulder Inverse /Reverse system is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Anatomical Shoulder primary humeral stem is intended for cemented or cementless use. The Anatomical Shoulder revision humeral stem is intended for cemented use only. The Anatomical Shoulder Inverse /Reverse glenoid fixation is intended for cementless, press-fit use. It requires screws for initial fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053274 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053274: Anatomical Shoulder Inverse/Reverse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053274
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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