510(k) · Cleared
ClearedAGILON® XO Shoulder Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantcast GmbH · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Feb 16, 2024 as substantially equivalent to K191433 (Implantcast GmbH, 2020) and 1 other predicate after a 254-day review. Its family tree reaches back 17 generations to 1991. 1 of the 170 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Feb 16, 2024
- Review
- 254 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K911686 (1991). 167 ancestors in all, the oldest K790987 (1979). 2 later devices descend from it, 2 citing it directly. 1 of the 170 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 backK181742 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2018
- 2 generations backK183039 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2019
- 1 generation backK191433 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
- This deviceK231657 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2024
- Descendant · cites it directly · 1 of its ownK241944 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2025
- Descendant · cites it directly · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
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 backK130895 Reunion Rsa Shoulder SystemHowmedica Osteonics Corp. · 2013
- 5 generations backK161863 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2016
- 4 generations backK172210 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker Trauma AG · 2017
- 3 generations backK181742 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2018
- 2 generations backK183039 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2019
- 1 generation backK191433 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
- This deviceK231657 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2024
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder6 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 | K130895 | Reunion Rsa Shoulder System | Howmedica Osteonics Corp. | 2013 | — |
| −5 | K161863 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2016 | — |
| −4 | K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker Trauma AG | 2017 | — |
| −3 | K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2018 | — |
| −2 | K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2019 | — |
| −1 | K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2020 | — |
| 0 (this device) | K231657 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2024 | — |
| +1 | K241944 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2025 | — |
| +1 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 11 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 0 |
| 1998 | 8 | 0 |
| 1999 | 6 | 0 |
| 2000 | 13 | 0 |
| 2001 | 9 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 10 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 KWT device
- #1 K222482 AGILON XO Shoulder Systemscore 17.3 · 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? (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 |
|---|---|---|---|
| * | K191433 | AGILON® XO Shoulder Replacement SystemSummary page 6…II Common Name: Shoulder Prosthesis Product Codes: KWT, HSD, PHX Primary Predicate: AGILON® XO Shoulder Replacement System (K191433) Additional Predicate: AGILON® XO Shoulder Replacement System (K222482) Indications For Use: The AGILON® XO Shoulder Repla… | 2020 |
| * | K222482 | AGILON XO Shoulder SystemSummary page 6…KWT, HSD, PHX Primary Predicate: AGILON® XO Shoulder Replacement System (K191433) Additional Predicate: AGILON® XO Shoulder Replacement System (K222482) Indications For Use: The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in… | 2022 |
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 · 6 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 12 months on median.
- 47 of the 167 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241944 (Implantcast GmbH, 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K191433.
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. 2024, 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 AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of: • Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, • Post-traumatic osteoarthritis, • Fractures, • Rheumatoid arthritis. The main indications for the implantation of an AGILON® hemi shoulder prosthesis are: • Multifragmental comminuted fractures of the humeral head, • 3- and 4-Fragment-fractures…
Read the full statement (414 words)
The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:
• Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• Post-traumatic osteoarthritis,
• Fractures,
• Rheumatoid arthritis.
The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:
• Multifragmental comminuted fractures of the humeral head,
• 3- and 4-Fragment-fractures of the proximal humerus,
• Head-splitting fractures,
• Dislocated head-splitting fractures,
• Humeral head depression with more than 40% of joint surface depressed,
• Interlocking chronic dislocation with deep HILL-SACHS lesion,
• Fracture instability following internal fixation attempt in 3-fragment and 4-fragment fractures (secondary dislocation, material loosening),
• Posttraumatic humeral head necrosis,
• Omarthrosis.
AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.
The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:
• Rotator cuff tear arthropathy,
• Chronic trauma shoulder,
• Decentering of the humeral head after implantation of a humeral head prosthesis.
Please note, that the patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.
In case of revision surgery, the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system, can be performed in revision cases as follows:
• From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
• From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
• From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
• From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
• From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
The device is intended for adults.
The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.
The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The glenoids cementless are intended for cementless use with the addition of screws for fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231657: AGILON® XO Shoulder Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231657
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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