510(k) · Cleared
ClearedAltiVate® Anatomic Shoulder AG e+™ with Markers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jun 23, 2023 as substantially equivalent to K213387 (Encore Medical L.P., 2022) and 3 other predicates after a 301-day review. Its family tree reaches back 15 generations to 1991.
- Decided
- Jun 23, 2023
- Review
- 301 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K911686 (1991). 146 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations between
- 3 generations backK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
- 2 generations backK203026 AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P. · 2020
- 1 generation backK213387 AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P. · 2022
- This deviceK222592 AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P. · 2023
Show all 15 generations
- Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 14 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 13 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 12 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 11 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 8 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 7 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 6 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 5 generations backK103208 Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011
- 4 generations backK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
- 3 generations backK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
- 2 generations backK203026 AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P. · 2020
- 1 generation backK213387 AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P. · 2022
- This deviceK222592 AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −14 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −11 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −8 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −7 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −6 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −5 | K103208 | Reverse Shoulder Prosthesis Monoblock Stem | Encore Medical L.P. | 2011 | — |
| −4 | K140904 | RSP Monoblock Stem with P2 Coating, Size 6 | Encore Medical L.P. | 2014 | — |
| −3 | K162024 | AltiVate Anatomic Shoulder System | Encore Medical L.P. | 2016 | 6 |
| −2 | K203026 | AltiVate® Anatomic Pegged Glenoid with Markers | Encore Medical L.P. | 2020 | — |
| −1 | K213387 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2022 | — |
| 0 (this device) | K222592 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2023 | — |
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 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 9 | 0 |
| 2001 | 11 | 0 |
| 2002 | 3 | 0 |
| 2003 | 9 | 0 |
| 2004 | 9 | 0 |
| 2005 | 7 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 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 KWS? 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? (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 |
|---|---|---|---|
| * | K213387 | AltiVate® Anatomic Shoulder AG e+™ with MarkersSummary page 4…88.3660) Regulatory Class: II Product Code(s): KWS, PAO III. PREDICATE DEVICES Primary Predicate: Encore Medical, L.P., AltiVate® Anatomic Shoulder AG e+™ with Markers, K213387 Additional Predicate: Exactech Equinoxe UHMWPE Posterior Augment Pegged Glenoids [K103419 (8ᵒ)/K111379 (12ᵒ)/ K121220 (16ᵒ)] I… | 2022 |
| * | K103419 | Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMSummary page 4…dicate: Encore Medical, L.P., AltiVate® Anatomic Shoulder AG e+™ with Markers, K213387 Additional Predicate: Exactech Equinoxe UHMWPE Posterior Augment Pegged Glenoids [K103419 (8ᵒ)/K111379 (12ᵒ)/ K121220 (16ᵒ)] IV. DEVICE DESCRIPTION This application is to include the AltiVate® Anatomic Shoulder AG e+™… | 2010 |
| * | K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Summary page 4…e Medical, L.P., AltiVate® Anatomic Shoulder AG e+™ with Markers, K213387 Additional Predicate: Exactech Equinoxe UHMWPE Posterior Augment Pegged Glenoids [K103419 (8ᵒ)/K111379 (12ᵒ)/ K121220 (16ᵒ)] IV. DEVICE DESCRIPTION This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers… | 2011 |
| * | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightSummary page 4…, AltiVate® Anatomic Shoulder AG e+™ with Markers, K213387 Additional Predicate: Exactech Equinoxe UHMWPE Posterior Augment Pegged Glenoids [K103419 (8ᵒ)/K111379 (12ᵒ)/ K121220 (16ᵒ)] IV. DEVICE DESCRIPTION This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers (Full-Wedge),… | 2012 |
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 32 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 45 of the 146 ancestors have a recall of any class.
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. 2023, 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 AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis Rheumatoid and other inflammatory arthritis Correction of functional deformity, including fracture malunion Humeral head fracture Revision of…
Read the full statement (109 words)
The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis
Rheumatoid and other inflammatory arthritis
Correction of functional deformity, including fracture malunion
Humeral head fracture
Revision of other devices if sufficient bone stock remains
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.
Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. Glenoid components are indicated for cemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222592: AltiVate® Anatomic Shoulder AG e+™ with Markers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222592
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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