510(k) · Cleared
ClearedInset Reverse Total Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shoulder Innovations, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Aug 20, 2021 as substantially equivalent to K080642 (Biomet, Inc., 2008) and 5 other predicates after a 177-day review. Its family tree reaches back 14 generations to 1991. 1 of the 85 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Aug 20, 2021
- Review
- 177 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K911686 (1991). 81 ancestors in all, the oldest K790987 (1979). 3 later devices descend from it, 2 citing it directly. 1 of the 85 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
- 2 generations backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- 1 generation backK172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard…Biomet Manufacturing Corp · 2018 · Recalled
- This deviceK210533 Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK252221 Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK254128 InSet Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252516 N22 EZ GlenosphereShoulder Innovations, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 3 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
- 2 generations backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- 1 generation backK172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard…Biomet Manufacturing Corp · 2018 · Recalled
- This deviceK210533 Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2021
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulderdirect predicate · 2008
Most influential descendants
Showing 3 of 3 · See all- K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2025 · cites it directly1descendant
- K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2026 · 2 generations on0descendants
- K252516N22 EZ GlenosphereShoulder Innovations, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −7 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −6 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −5 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −4 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −3 | K093803 | Bio-Modular Reverse Sholder | Biomet Manufacturing Corp | 2010 | — |
| −2 | K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | Biomet Manufacturing Corp | 2013 | — |
| −1 | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate… | Biomet Manufacturing Corp | 2018 | 1 |
| 0 (this device) | K210533 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2021 | — |
| +1 | K252221 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2025 | — |
| +2 | K254128 | InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2026 | — |
| +1 | K252516 | N22 EZ Glenosphere | Shoulder Innovations, 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 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K080642 | Comprehensive Reverse ShoulderSummary page 4…emented prosthesis; Class II Product Code MBF Review Panel: Orthopedic Primary Predicate Device: Biomet Comprehensive Reverse Shoulder (K080642) Secondary Predicate Devices: Biomet Comprehensive Reverse Shoulder Humeral Tray (K113069)… | 2008 |
| * | K113069 | Comprehensive Reverse Shoulder Humeral TraySummary page 4…icate Device: Biomet Comprehensive Reverse Shoulder (K080642) Secondary Predicate Devices: Biomet Comprehensive Reverse Shoulder Humeral Tray (K113069) Biomet Comprehensive Reverse Shoulder Mini Baseplate (K120121) B… | 2012 |
| * | K120121 | Comprehensive Reverse Shoulder-Mini BaseplateSummary page 4…omprehensive Reverse Shoulder Humeral Tray (K113069) Biomet Comprehensive Reverse Shoulder Mini Baseplate (K120121) Biomet Comprehensive Reverse Shoulder – Titanium Glenosphere (K131353) === Page 5 ==… | 2012 |
| * | K131353 | Comprehensive Reverse Shoulder - Titanium GlenosphereSummary page 4…e Reverse Shoulder Mini Baseplate (K120121) Biomet Comprehensive Reverse Shoulder – Titanium Glenosphere (K131353) K210533 2 of 5… | 2013 |
| * | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Summary page 5…Biomet Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate (K172502) Biomet Comprehensive Reverse Shoulder System (K181611) Intended Use / Indications: The Inset Reve… | 2018 |
| * | K181611 | Comprehensive Reverse Shoulder SystemSummary page 5…mprehensive Standard Baseplate, Comprehensive Mini Baseplate (K172502) Biomet Comprehensive Reverse Shoulder System (K181611) Intended Use / Indications: The Inset Reverse Total Shoulder System should be used in patients whose shoulder joint has a gr… | 2018 |
What descends from it? (3)
2 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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 26 of the 81 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K252221 (Shoulder Innovations, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 23 other devices also cite its predicate K080642.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Inset Reverse Total Shoulder System should be used in patients whose shoulder joint has a grossly deficient rotator cuffwith 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 Inset Reverse Total Shoulder System is indicated for primary or revision total shoulder…
Read the full statement (107 words)
The Inset Reverse Total Shoulder System should be used in patients whose shoulder joint has a grossly deficient rotator cuffwith 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 Inset Reverse Total Shoulder System is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Glenoid Baseplate is intended for cementless application with the addition of screw fixation. The Humeral Stem may be implanted by press-fit or cement fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210533: Inset Reverse Total 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/K210533
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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