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 Jul 7, 2022 as substantially equivalent to K203026 (Encore Medical L.P., 2020) and 1 other predicate after a 266-day review. Its family tree reaches back 14 generations to 1991. 1 later device descends from it.
- Decided
- Jul 7, 2022
- Review
- 266 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K911686 (1991). 114 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
- 2 generations backK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
- 1 generation backK203026 AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P. · 2020
- This deviceK213387 AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P. · 2022
- Descendant · cites it directly · 0 of its ownK222592 AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P. · 2023
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 7 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 6 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 5 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 4 generations backK103208 Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011
- 3 generations backK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
- 2 generations backK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
- 1 generation backK203026 AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P. · 2020
- This deviceK213387 AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −7 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −6 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −5 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −4 | K103208 | Reverse Shoulder Prosthesis Monoblock Stem | Encore Medical L.P. | 2011 | — |
| −3 | K140904 | RSP Monoblock Stem with P2 Coating, Size 6 | Encore Medical L.P. | 2014 | — |
| −2 | K162024 | AltiVate Anatomic Shoulder System | Encore Medical L.P. | 2016 | 6 |
| −1 | K203026 | AltiVate® Anatomic Pegged Glenoid with Markers | Encore Medical L.P. | 2020 | — |
| 0 (this device) | K213387 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2022 | — |
| +1 | 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 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 2 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K203026 | AltiVate® Anatomic Pegged Glenoid with MarkersSummary page 4…cemented prosthesis (888.3660) Regulatory Class: II Product Code(s): KWS, PAO III. PREDICATE DEVICE Encore Medical, L.P., AltiVate Anatomic Pegged Glenoid with Markers, K203026 (Primary Predicate) Encore Medical, L.P., AltiVate Anatomic Shoulder, K162024 Reference devices: Tornier, Inc., Aequalis PerFORM… | 2020 |
| * | K162024 | AltiVate Anatomic Shoulder SystemSummary page 4…III. PREDICATE DEVICE Encore Medical, L.P., AltiVate Anatomic Pegged Glenoid with Markers, K203026 (Primary Predicate) Encore Medical, L.P., AltiVate Anatomic Shoulder, K162024 Reference devices: Tornier, Inc., Aequalis PerFORM+ Shoulder System, K150583 Encore Orthopedics, Inc., Total Shoulder Prosthesis… | 2016 |
| † | K150583 | Aequalis PerFORM+ Shoulder System | 2015 |
| † | K950651 | Total Shoulder Prosthesis | 1995 |
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 |
|---|---|---|---|
| K222592 | AltiVate® Anatomic Shoulder AG e+™ with Markers | 2023 | 0 |
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 31 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 31 of the 114 ancestors have a recall of any class.
- Of its descendants, K222592 (Encore Medical L.P., 2023) has gone furthest, with 0 descendants of its own.
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 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 •…
Read the full statement (114 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 as stated in the FDA summary.
https://510kreport.com/device/K213387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213387: 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/K213387
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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