510(k) · Cleared
ClearedCatalyst OrthoScience CSR Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catalyst Orthoscience, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Sep 11, 2019 as substantially equivalent to K173812 (Catalyst Orthoscience, Inc., 2018) and 2 other predicates after a 68-day review. Its family tree reaches back 13 generations to 1993.
- Decided
- Sep 11, 2019
- Review
- 68 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K920362 (1993). 85 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 9 generations between
- 3 generations backK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015
- 2 generations backK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
- 1 generation backK173812 Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc. · 2018
- This deviceK191811 Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2019
Show all 13 generations
- Root · 13 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 12 generations backK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
- 11 generations backK032679 Aequalis Shoulder Fracture SystemTornier · 2003
- 10 generations backK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
- 9 generations backK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
- 8 generations backK081707 Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc. · 2008
- 7 generations backK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
- 6 generations backK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
- 5 generations backK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
- 4 generations backK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
- 3 generations backK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015
- 2 generations backK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
- 1 generation backK173812 Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc. · 2018
- This deviceK191811 Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K920362 | 3M Modular Shoulder System | 3M Health Care, Ltd. | 1993 | — |
| −12 | K002683 | WMT Ultra-Fit Modular Shoulder System | Wrightmedicaltechnologyinc | 2000 | — |
| −11 | K032679 | Aequalis Shoulder Fracture System | Tornier | 2003 | — |
| −10 | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | Tornier | 2004 | — |
| −9 | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | Tornier | 2006 | — |
| −8 | K081707 | Aequalis Shoulder Fracture and Shoulder Systems | Tornier, Inc. | 2008 | — |
| −7 | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage… | Exactech, Inc. | 2010 | 1 |
| −6 | K103419 | Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM | Exactech, Inc. | 2010 | 2 |
| −5 | K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /… | Exactech, Inc. | 2011 | 2 |
| −4 | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right | Exactech, Inc. | 2012 | 2 |
| −3 | K150583 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | 2015 | — |
| −2 | K152825 | Catalyst CSR Shoulder System | Catalyst Orthoscience, LLC | 2016 | — |
| −1 | K173812 | Catalyst CSR 3 Peg Glenoids | Catalyst Orthoscience, Inc. | 2018 | — |
| 0 (this device) | K191811 | Catalyst OrthoScience CSR Shoulder System | Catalyst Orthoscience, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1987 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 9 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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.
Planning a device in KWT? 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K173812 | Catalyst CSR 3 Peg GlenoidsSummary page 4…cemented prosthesis; Class II Product Codes: KWT Substantially Equivalent Devices: Catalyst OrthoScience CSR 3 Peg Glenoids, K173812 Exactech® Equinoxe® UHMWPE 16° Posterior Augment Pegged… | 2018 |
| * | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightSummary page 4…CSR 3 Peg Glenoids, K173812 Exactech® Equinoxe® UHMWPE 16° Posterior Augment Pegged Glenoids, K121220 DePuy Anchor Peg Glenoid, K981487 Device Description: The Catalyst CSR Shoulder System is a bo… | 2012 |
| * | K981487 | Depuy Global Shoulder GlenoidSummary page 4…actech® Equinoxe® UHMWPE 16° Posterior Augment Pegged Glenoids, K121220 DePuy Anchor Peg Glenoid, K981487 Device Description: The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 21 of the 85 ancestors have a recall of any class.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Catalyst CSR Shoulder System 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 CSR Shoulder System 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…
Read the full statement (115 words)
The Catalyst CSR Shoulder System 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 CSR Shoulder System 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 CSR humeral and glenoid implants are intended for cemented use.
The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191811: Catalyst OrthoScience CSR 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/K191811
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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