510(k) · Cleared
ClearedCatalyst F1x 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 Apr 5, 2024 as substantially equivalent to K161189 (Integra LifeSciences Corporation, 2016) and 3 other predicates after a 101-day review. Its family tree reaches back 20 generations to 1991. 1 of the 213 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 5, 2024
- Review
- 101 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 20 generations to K911686 (1991). 212 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 213 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 16 generations between
- 3 generations backK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- 2 generations backK211991 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- 1 generation backK232583 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2023
- This deviceK234105 Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2024
Show all 20 generations
- Root · 20 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 19 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 18 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 17 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 16 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 15 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 14 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 13 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 12 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 11 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 10 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 9 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 8 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 7 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 6 generations backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- 5 generations backK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- 4 generations backK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
- 3 generations backK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- 2 generations backK211991 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- 1 generation backK232583 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2023
- This deviceK234105 Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2024
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder4 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −19 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −18 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −17 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −16 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −15 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −14 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −13 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −12 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −11 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −10 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −9 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −8 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −7 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −6 | K141990 | Encore Humeral Shoulder Stem | Encore Medical L.P. | 2014 | 3 |
| −5 | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate… | Encore Medical L.P. | 2017 | 3 |
| −4 | K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. | 2019 | — |
| −3 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| −2 | K211991 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| −1 | K232583 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2023 | — |
| 0 (this device) | K234105 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2024 | — |
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 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 10 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 12 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 10 | 0 |
| 2006 | 12 | 0 |
| 2007 | 8 | 0 |
| 2008 | 10 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 9 | 0 |
| 2012 | 7 | 0 |
| 2013 | 9 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K161189 | Integra TITAN Reverse Shoulder SystemSummary page 4…ined cemented prosthesis; Class II Product Code: PHX Primary Predicate: Integra Titan Reverse Shoulder System (K161189) Additional Predicate: Catalyst R1 Shoulder System (K213349, K232583 and K202611) Device Description: The Catalyst F1x… | 2016 |
| * | K213349 | Catalyst R1 Reverse Shoulder SystemSummary page 4…duct Code: PHX Primary Predicate: Integra Titan Reverse Shoulder System (K161189) Additional Predicate: Catalyst R1 Shoulder System (K213349, K232583 and K202611) Device Description: The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joi… | 2022 |
| * | K232583 | Catalyst R1 Reverse Shoulder SystemSummary page 4…: PHX Primary Predicate: Integra Titan Reverse Shoulder System (K161189) Additional Predicate: Catalyst R1 Shoulder System (K213349, K232583 and K202611) Device Description: The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in re… | 2023 |
| * | K202611 | Catalyst OrthoScience R1 Reverse Shoulder SystemSummary page 4…PHX Primary Predicate: Integra Titan Reverse Shoulder System (K161189) Additional Predicate: Catalyst R1 Shoulder System (K213349, K232583 and K202611) Device Description: The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in reverse arthro… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 60 of the 212 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K161189.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 F1x 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 (144 words)
The Catalyst F1x 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;
• 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 Catalyst F1x press-fit stems are intended for cementless press-fit applications.
The Catalyst F1x cemented stems are intended for cemented fixation.
The Catalyst F1x stem is compatible with the implants from the R1 Shoulder Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234105 · printed Nov 5, 2026
Cite this page
510(k) Report. “K234105: Catalyst F1x Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K234105
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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