510(k) · Cleared
ClearedCatalyst 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 Jul 12, 2018 as substantially equivalent to K152825 (Catalyst Orthoscience, LLC, 2016) after a 57-day review. Its family tree reaches back 12 generations to 1993. 3 later devices descend from it.
- Decided
- Jul 12, 2018
- Review
- 57 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K920362 (1993). 84 ancestors in all, the oldest K790987 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 8 generations between
- 3 generations backK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
- 2 generations backK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015
- 1 generation backK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
- This deviceK181287 Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK182500 Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK222317 Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK252418 Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 11 generations backK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
- 10 generations backK032679 Aequalis Shoulder Fracture SystemTornier · 2003
- 9 generations backK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
- 8 generations backK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
- 7 generations backK081707 Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc. · 2008
- 6 generations backK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
- 5 generations backK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
- 4 generations backK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
- 3 generations backK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
- 2 generations backK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015
- 1 generation backK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
- This deviceK181287 Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc. · 2019 · cites it directly2descendants
- K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc. · 2022 · 2 generations on1descendant
- K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K920362 | 3M Modular Shoulder System | 3M Health Care, Ltd. | 1993 | — |
| −11 | K002683 | WMT Ultra-Fit Modular Shoulder System | Wrightmedicaltechnologyinc | 2000 | — |
| −10 | K032679 | Aequalis Shoulder Fracture System | Tornier | 2003 | — |
| −9 | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | Tornier | 2004 | — |
| −8 | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | Tornier | 2006 | — |
| −7 | K081707 | Aequalis Shoulder Fracture and Shoulder Systems | Tornier, Inc. | 2008 | — |
| −6 | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage… | Exactech, Inc. | 2010 | 1 |
| −5 | K103419 | Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM | Exactech, Inc. | 2010 | 2 |
| −4 | K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /… | Exactech, Inc. | 2011 | 2 |
| −3 | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right | Exactech, Inc. | 2012 | 2 |
| −2 | K150583 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | 2015 | — |
| −1 | K152825 | Catalyst CSR Shoulder System | Catalyst Orthoscience, LLC | 2016 | — |
| 0 (this device) | K181287 | Catalyst CSR Shoulder System | Catalyst Orthoscience, Inc. | 2018 | — |
| +1 | K182500 | Catalyst CSR Press-Fit Humeral Components | Catalyst Orthoscience, Inc. | 2019 | — |
| +2 | K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | 2022 | — |
| +3 | 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 |
| 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 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.
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? (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 |
|---|---|---|---|
| * | K152825 | Catalyst CSR Shoulder SystemSummary page 4…llic uncemented prosthesis; Class II Product Codes: KWT, HSD Substantially Equivalent Device: w Catalyst OrthoScience CSR Shoulder System (K152825) Reference Devices: w Biomet Versa-Dial Humeral Head Prosthesis (K060716) w Zimmer… | 2016 |
| † | K060716 | Versa-Dial Humeral Head Prosthesis | 2006 |
| † | K053274 | Anatomical Shoulder Inverse/Reverse | 2006 |
| † | K051623 | Anatomical Shoulder Keeled Glenoid | 2005 |
| † | K160975 | Aequalis PerFORM+ Shoulder System | 2016 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182500 | Catalyst CSR Press-Fit Humeral Components | 2019 | 2 |
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 25 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 21 of the 84 ancestors have a recall of any class.
- Of its descendants, K182500 (Catalyst Orthoscience, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K152825.
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. 2018, 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 reconstructable.
• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity
Both components of the Catalyst CSR Shoulder System are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181287 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181287: Catalyst CSR 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/K181287
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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