510(k) · Cleared
ClearedReunion Rsa Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Dec 27, 2013 as substantially equivalent to K080642 (Biomet, Inc., 2008) and 5 other predicates after a 270-day review. Its family tree reaches back 11 generations to 1991. 1 of the 99 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Dec 27, 2013
- Review
- 270 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K911686 (1991). 84 ancestors in all, the oldest K790987 (1979). 14 later devices descend from it, 1 citing it directly. 1 of the 99 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations between
- 3 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 2 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 1 generation backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- This deviceK130895 Reunion Rsa Shoulder SystemHowmedica Osteonics Corp. · 2013
- Descendant · cites it directly · 13 of its ownK161863 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2016
- Descendant · 2 generations on · 10 of its ownK172210 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker Trauma AG · 2017
- Descendant · 3 generations on · 9 of its ownK181742 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2018
- Descendant · 4 generations on · 8 of its ownK183039 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2019
- Descendant · 5 generations on · 3 of its ownK191433 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
Show all 11 generations
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 9 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 8 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 7 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 4 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 3 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 2 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 1 generation backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- This deviceK130895 Reunion Rsa Shoulder SystemHowmedica Osteonics Corp. · 2013
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulderdirect predicate · 2008
Most influential descendants
Showing 5 of 14 · See all- K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH · 2016 · cites it directly13descendants
- K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG · 2017 · 2 generations on10descendants
- K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH · 2018 · 3 generations on9descendants
- K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH · 2019 · 4 generations on8descendants
- K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −10 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −7 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −4 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −3 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −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 |
| 0 (this device) | K130895 | Reunion Rsa Shoulder System | Howmedica Osteonics Corp. | 2013 | — |
| +1 | K161863 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2016 | — |
| +2 | K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker Trauma AG | 2017 | — |
| +3 | K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2018 | — |
| +4 | K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2019 | — |
| +5 | K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2020 | — |
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 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 9 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 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…h, NJ 07430 Phone: (201) 831-5718 Fax: (201) 831-4718 karen.ariemmatastryker.com March 28, 2013 Legally Marketed Device to Which Substantial Equivalence is Claimed: e K080642 & K072804-Comprehensive Reverse Shoulder (Biomet) Description: K112069- Reverse Shoulder System (DJO Encore) KO081171-Tritanium… | 2008 |
| * | K072804 | Comprehensive RS Shoulder SystemSummary page 4…0 Phone: (201) 831-5718 Fax: (201) 831-4718 karen.ariemmatastryker.com March 28, 2013 Legally Marketed Device to Which Substantial Equivalence is Claimed: e K080642 & K072804-Comprehensive Reverse Shoulder (Biomet) Description: K112069- Reverse Shoulder System (DJO Encore) KO081171-Tritanium Acetabula… | 2007 |
| * | K112069 | RSP Glenoid Baseplate Porous CoatedSummary page 4…ryker.com March 28, 2013 Legally Marketed Device to Which Substantial Equivalence is Claimed: e K080642 & K072804-Comprehensive Reverse Shoulder (Biomet) Description: K112069- Reverse Shoulder System (DJO Encore) KO081171-Tritanium Acetabular Shell (Howmedica Osteonics) K062250-Delta Xtend Reverse Shoul… | 2011 |
| * | K081171 | Tritanium Acetabular Shell SystemSummary page 4…e to Which Substantial Equivalence is Claimed: e K080642 & K072804-Comprehensive Reverse Shoulder (Biomet) Description: K112069- Reverse Shoulder System (DJO Encore) KO081171-Tritanium Acetabular Shell (Howmedica Osteonics) K062250-Delta Xtend Reverse Shoulder System (DePuy) K021478-Delta Shoulder (DePu… | 2008 |
| * | K062250 | Delta Xtend Reverse Shoulder SystemSummary page 4…& K072804-Comprehensive Reverse Shoulder (Biomet) Description: K112069- Reverse Shoulder System (DJO Encore) KO081171-Tritanium Acetabular Shell (Howmedica Osteonics) K062250-Delta Xtend Reverse Shoulder System (DePuy) K021478-Delta Shoulder (DePuy) This Traditional 510(k) submission is being supplied… | 2007 |
| * | K021478 | Delta ShoulderSummary page 4…Description: K112069- Reverse Shoulder System (DJO Encore) KO081171-Tritanium Acetabular Shell (Howmedica Osteonics) K062250-Delta Xtend Reverse Shoulder System (DePuy) K021478-Delta Shoulder (DePuy) This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to " marke… | 2003 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161863 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)… | 2016 | 13 |
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 22 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 29 of the 84 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K161863 (Stryker GmbH, 2016) has gone furthest, with 13 descendants 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. 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 ReUnion RSA Shoulder System is intended for primary, fracture, or revision
total shoulder replacement. The patient’s joint must have gross rotator cuff
deficiency, a functional deltoid muscle and be anatomically and structurally suited to
receive the selected implant(s).
• Painful, disabling joint disease of the shoulder resulting from: degenerative
arthritis or rheumatoid arthritis
• Proximal humeral fracture
Revision of previously failed shoulder joint replacement
• Glenoid Baseplate components are intended for cementless use with the
addition of screw fixation. The humeral stem components are intended for
both cemented and cementless use.
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/K130895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130895: Reunion Rsa 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/K130895
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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