510(k) · Cleared
ClearedCatalyst R1 Reverse Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catalyst Orthoscience, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jun 23, 2022 as substantially equivalent to K190290 (Encore Medical L.P., 2019) after a 258-day review. Its family tree reaches back 17 generations to 1991. 1 of the 153 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jun 23, 2022
- Review
- 258 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K911686 (1991). 150 ancestors in all, the oldest K790987 (1979). 2 later devices descend from it, 2 citing it directly. 1 of the 153 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations between
- 3 generations backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- 2 generations backK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- 1 generation backK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
- This deviceK213349 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK234105 Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK223655 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2023
Show all 17 generations
- Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 16 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 15 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 14 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 13 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 12 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 10 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 9 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 8 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 7 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 6 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 5 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 4 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 3 generations backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- 2 generations backK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- 1 generation backK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
- This deviceK213349 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2022
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder5 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −16 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −15 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −13 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −12 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −10 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −9 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −8 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −7 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −6 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −5 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −4 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −3 | K141990 | Encore Humeral Shoulder Stem | Encore Medical L.P. | 2014 | 3 |
| −2 | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate… | Encore Medical L.P. | 2017 | 3 |
| −1 | K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. | 2019 | — |
| 0 (this device) | K213349 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2022 | — |
| +1 | K234105 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2024 | — |
| +1 | K223655 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 8 | 0 |
| 2006 | 9 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K190290 | AltiVate Reverse Humeral Stem, 48mmSummary page 4…oulder Prosthesis, Hemi-, Humeral, Metallic, Uncemented Primary Predicate: Encore Medical (DJO) Altivate Reverse Shoulder System (K190290) Device Description: The Catalyst R1 Reverse Shoulder System is a total shoulder prosthesis designed for use in patients with a… | 2019 |
What descends from it? (2)
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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 43 of the 150 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K234105 (Catalyst Orthoscience, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K190290.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Catalyst R1 Reverse Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: * Severe arthropathy with a grossly deficient rotator cuff; * Previously failed joint replacement with a grossly deficient rotator cuff; * Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head…
Read the full statement (141 words)
The Catalyst R1 Reverse Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
* Severe arthropathy with a grossly deficient rotator cuff;
* Previously failed joint replacement with a grossly deficient rotator cuff;
* Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
* Bone defect in proximal humerus;
* Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
* Inflammatory arthritis including rheumatoid arthritis;
* Correction of functional deformity
The humeral stems are intended for cemented or uncemented applications.
The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213349: Catalyst R1 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/K213349
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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