510(k) · Cleared
ClearedComprehensive Reverse Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Sep 24, 2018 as substantially equivalent to K113069 (Biomet Manufacturing Corp, 2012) and 2 other predicates after a 97-day review. Its family tree reaches back 13 generations to 1991. 1 of the 88 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Sep 24, 2018
- Review
- 97 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K911686 (1991). 77 ancestors in all, the oldest K790987 (1979). 10 later devices descend from it, 4 citing it directly. 1 of the 88 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations between
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
- 1 generation backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- This deviceK181611 Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp · 2018
- Descendant · cites it directly · 3 of its ownK210533 Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK200368 LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
- Descendant · 2 generations on · 1 of its ownK252221 Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK240876 Identity Shoulder SystemZimmer, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253592 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral…Zimmer, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 6 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 5 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 4 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
- 1 generation backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- This deviceK181611 Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations back · 2008
Most influential descendants
Showing 5 of 10 · See all- K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2021 · cites it directly3descendants
- K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021 · cites it directly3descendants
- K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2025 · 2 generations on1descendant
- K240876Identity Shoulder SystemZimmer, Inc. · 2024 · cites it directly1descendant
- K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −12 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −9 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −6 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −5 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −4 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −3 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −2 | K093803 | Bio-Modular Reverse Sholder | Biomet Manufacturing Corp | 2010 | — |
| −1 | K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | Biomet Manufacturing Corp | 2013 | — |
| 0 (this device) | K181611 | Comprehensive Reverse Shoulder System | Biomet Manufacturing Corp | 2018 | — |
| +1 | K210533 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2021 | — |
| +1 | K200368 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021 | — |
| +2 | K252221 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2025 | — |
| +1 | K240876 | Identity Shoulder System | Zimmer, Inc. | 2024 | — |
| +1 | K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity… | Zimmer, Inc. | 2026 | — |
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 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (3)
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 |
|---|---|---|---|
| * | K113069 | Comprehensive Reverse Shoulder Humeral TraySummary page 4…t, metal/polymer, non-constrained, cemented prosthesis (21 CFR 888.3650) Predicate Device(s): K113069 Comprehensive Reverse Biomet (Primary) Humeral Shoulder Tray… | 2012 |
| * | K131353 | Comprehensive Reverse Shoulder - Titanium GlenosphereSummary page 4…nsive Reverse Biomet (Primary) Humeral Shoulder Tray Manufacturing Corp K131353 Comprehensive Reverse Biomet Shoulder – Titanium… | 2013 |
| * | K133378 | Zimmer Trabecular Metal Reverse Shoulder SystemSummary page 4…Shoulder – Titanium Manufacturing Corp Glenosphere K133378 Trabecular Metal Reverse Zimmer, Inc. Shoulder System, Vivacit… | 2014 |
| † | K080642 | Comprehensive Reverse Shoulder | 2008 |
| † | K013991 | Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface… | 2001 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 24 of the 77 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K210533 (Shoulder Innovations, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K113069.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Comprehensive Reverse Shoulder products are 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…
Read the full statement (211 words)
Comprehensive Reverse Shoulder products are 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.
Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.
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.
Interlok® 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 as stated in the FDA summary.
https://510kreport.com/device/K181611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181611: Comprehensive 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/K181611
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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