510(k) · Cleared
Recalled · Class I · 2020Comprehensive Reverse Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jul 9, 2008 as substantially equivalent to K072804 (Biomet Manufacturing Corp, 2007) and 6 other predicates after a 125-day review. Its family tree reaches back 10 generations to 1991. 1 of the 224 devices in its family, counting itself, has a Class I recall. 172 later devices descend from it. It has been recalled 17 times, including a Class I recall.
- Decided
- Jul 9, 2008
- Review
- 125 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 17 (1 Class I)
- Predicates
- 7
Its longest line of descent runs back 10 generations to K911686 (1991). 51 ancestors in all, the oldest K790987 (1979). 172 later devices descend from it, 24 citing it directly. 1 of the 224 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations between
- 3 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 2 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 1 generation backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- This deviceK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008
- Descendant · cites it directly · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 2 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 3 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- Descendant · cites it directly · 69 of its ownK120121 Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc. · 2012 · Recalled
- Descendant · cites it directly · 61 of its ownK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
Show all 10 generations
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 8 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 7 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 6 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 4 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 3 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 2 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 1 generation backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- This deviceK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008
Showing 5 of 172 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 172 · See all- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · cites it directly108descendants
- K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on97descendants
- K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 3 generations on96descendants
- K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc. · 2012 · cites it directly69descendants
- K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010 · cites it directly61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −9 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −6 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −4 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −3 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −2 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −1 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| 0 (this device) | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | — |
| +1 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +2 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +3 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| +1 | K120121 | Comprehensive Reverse Shoulder-Mini Baseplate | Biomet, Inc. | 2012 | 4 |
| +1 | K093803 | Bio-Modular Reverse Sholder | Biomet Manufacturing Corp | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 9 | 0 |
| 2018 | 9 | 0 |
| 2019 | 13 | 0 |
| 2020 | 13 | 0 |
| 2021 | 21 | 0 |
| 2022 | 16 | 0 |
| 2023 | 13 | 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? (7)
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 |
|---|---|---|---|
| * | K072804 | Comprehensive RS Shoulder SystemSummary page 4…, semi-constrained, cemented prosthesis (21 CFR 888.3660) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Comprehensive® RS Shoulder Biomet, Inc. K072804 Anatomical Shoulder™ Inverse/Reverse Zimmer, Inc. K053274 Equinoxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Rev… | 2007 |
| * | K053274 | Anatomical Shoulder Inverse/ReverseSummary page 4…Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Comprehensive® RS Shoulder Biomet, Inc. K072804 Anatomical Shoulder™ Inverse/Reverse Zimmer, Inc. K053274 Equinoxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Reverse Shoulder Prosthesis Encore Medical K041066, K051075 Tr… | 2006 |
| * | K063569 | Equinoxe Reverse Shoulder SystemSummary page 4…alence Is Claimed: Comprehensive® RS Shoulder Biomet, Inc. K072804 Anatomical Shoulder™ Inverse/Reverse Zimmer, Inc. K053274 Equinoxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Reverse Shoulder Prosthesis Encore Medical K041066, K051075 Trabecular Metal™ Reverse Shoulder Zimmer, Inc. K0529… | 2007 |
| * | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | 2008 |
| * | K041066 | Encore Reverse Shoulder ProsthesisSummary page 4…Anatomical Shoulder™ Inverse/Reverse Zimmer, Inc. K053274 Equinoxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Reverse Shoulder Prosthesis Encore Medical K041066, K051075 Trabecular Metal™ Reverse Shoulder Zimmer, Inc. K052906 Device Description: The Comprehensive® Reverse Shoulder is inte… | 2005 |
| * | K051075 | Encore Reverse Shoulder ProsthesisSummary page 4…al Shoulder™ Inverse/Reverse Zimmer, Inc. K053274 Equinoxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Reverse Shoulder Prosthesis Encore Medical K041066, K051075 Trabecular Metal™ Reverse Shoulder Zimmer, Inc. K052906 Device Description: The Comprehensive® Reverse Shoulder is intended for… | 2005 |
| * | K052906 | Zimmer Trabecular Metal Reverse Shoulder SystemSummary page 4…oxe® Reverse Shoulder System Exactech K063569, KO73688 Encore Reverse Shoulder Prosthesis Encore Medical K041066, K051075 Trabecular Metal™ Reverse Shoulder Zimmer, Inc. K052906 Device Description: The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configu… | 2005 |
What descends from it? (172)
See all 17224 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110599 | Aequalis Ascend Modular Reverse Shoulder System | 2011 | 108 |
| K120121 | Comprehensive Reverse Shoulder-Mini Baseplate | 2012 | 69 |
| K093803 | Bio-Modular Reverse Sholder | 2010 | 61 |
| K120174 | Deput Delta Xtend Reverse Shoulder | 2012 | 41 |
| K113069 | Comprehensive Reverse Shoulder Humeral Tray | 2012 | 35 |
| K113121 | Comprehensive Reverse Shoulder | 2011 | 31 |
| K132239 | Comprehensive Reverse Shoulder Screws | 2013 | 25 |
| K193373 | Comprehensive® Reverse Shoulder | 2020 | 20 |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate… | 2018 | 20 |
| K130895 | Reunion Rsa Shoulder System | 2013 | 14 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2020 | Class II | Z-2144-2020 | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit |
| Mar 13, 2020 | Class II | Z-1750-2020 | Under Investigation by firm | There were unknown bioburden levels prior to sterilization, which may affect sterility of the product. |
| Feb 17, 2017 | Class II | Z-1859-2017 | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. |
| Dec 20, 2016 | Class I | Z-1103-2017 | Device Design | Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing. |
| May 15, 2013 | Class II | Z-1548-2013 | Device Design | Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin… |
| Apr 22, 2011 | Not classified | Z-2541-2011 | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. |
| Apr 22, 2011 | Not classified | Z-2544-2011 | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. |
| Apr 22, 2011 | Not classified | Z-2548-2011 | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. |
| Apr 22, 2011 | Not classified | Z-2549-2011 | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. |
| Apr 22, 2011 | Not classified | Z-2547-2011 | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. |
| Apr 22, 2011 | Not classified | Z-2546-2011 | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. |
| Apr 22, 2011 | Not classified | Z-2545-2011 | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. |
| Apr 22, 2011 | Not classified | Z-2550-2011 | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. |
| Apr 22, 2011 | Not classified | Z-2542-2011 | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. |
| Apr 22, 2011 | Not classified | Z-2543-2011 | Employee error | The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled. |
| Sep 13, 2010 | Not classified | Z-0712-2011 | Pending | The firm received complaints regarding fracturing of the device. |
| Sep 13, 2010 | Not classified | Z-0713-2011 | Pending | The firm received complaints regarding fracturing of the device. |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 17 of the 51 ancestors have a recall of any class.
- Of its descendants, K110599 (Tornier, Inc., 2011) has gone furthest, with 108 descendants of its own.
- 2 other devices also cite its predicate K072804.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Comprehensive® Reverse Shoulder 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 Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total…
Read the full statement (154 words)
The Comprehensive® Reverse Shoulder 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 Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.
Intertok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation 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/K080642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080642: Comprehensive Reverse Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080642
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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