510(k) · Cleared
ClearedCatalyst EA Convertible Stemmed Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catalyst Orthoscience, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Nov 10, 2022 as substantially equivalent to K172351 (Encore Medical L.P., 2017) and 1 other predicate after a 100-day review. Its family tree reaches back 16 generations to 1991. 1 of the 190 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Nov 10, 2022
- Review
- 100 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K911686 (1991). 188 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 190 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations between
- 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- 1 generation backK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- This deviceK222317 Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK252418 Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025
Show all 16 generations
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 15 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 14 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 13 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 12 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 9 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 8 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 7 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 6 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 5 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 4 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- 1 generation backK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- This deviceK222317 Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc. · 2022
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder6 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −15 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −12 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −9 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −8 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −7 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −6 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −5 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −4 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −3 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −2 | K141990 | Encore Humeral Shoulder Stem | Encore Medical L.P. | 2014 | 3 |
| −1 | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate… | Encore Medical L.P. | 2017 | 3 |
| 0 (this device) | K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | 2022 | — |
| +1 | K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2025 | — |
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 | 4 | 0 |
| 1995 | 9 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 11 | 0 |
| 2002 | 4 | 0 |
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 9 | 0 |
| 2006 | 11 | 0 |
| 2007 | 9 | 0 |
| 2008 | 8 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Summary page 5…metallic uncemented prosthesis; Class II Product Code: KWS, HSD, PHX Primary Predicate: Encore Medical (DJO) AltiVate Shoulder System K172351 Secondary Predicate: Catalyst CSR Shoulder System, K182500 Device Description: The Catalyst EA Convertible Stemmed Shou… | 2017 |
| * | K182500 | Catalyst CSR Press-Fit Humeral ComponentsSummary page 5…KWS, HSD, PHX Primary Predicate: Encore Medical (DJO) AltiVate Shoulder System K172351 Secondary Predicate: Catalyst CSR Shoulder System, K182500 Device Description: The Catalyst EA Convertible Stemmed Shoulder is an anatomic designed total shoulder prosthesis that mates wi… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252418 | Catalyst F1x Shoulder System | 2025 | 0 |
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 · 6 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.
- 56 of the 188 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K252418 (Catalyst Orthoscience, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K172351.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged. Anatomic Total Shoulder or Hemi-Shoulder The Catalyst EA Convertible Stemmed Shoulder is indicated for use in skeletally mature…
Read the full statement (320 words)
The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.
Anatomic Total Shoulder or Hemi-Shoulder
The Catalyst EA Convertible Stemmed Shoulder is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst EA Convertible Stemmed Shoulder is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.
• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity
The Catalyst 3-Peg glenoid implants are intended for cemented use only.
The Catalyst R1 Reverse Shoulder humeral stems are intended for cemented or uncemented applications.
Reverse Total Shoulder
The Catalyst EA Convertible Stemmed Shoulder 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 Catalyst R1 Shoulder humeral stems are intended for uncemented or cemented 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/K222317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222317: Catalyst EA Convertible Stemmed Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222317
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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