510(k) · Cleared
ClearedAltiVate Anatomic Canal-Sparing (CS) Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Cleared on Jun 3, 2020 as substantially equivalent to K143552 (Tornier, Inc., 2015) and 1 other predicate after a 194-day review. Its family tree reaches back 13 generations to 1991. 4 later devices descend from it.
- Decided
- Jun 3, 2020
- Review
- 194 days
- Class
- Class II
- Product code
- PKC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K911686 (1991). 116 ancestors in all, the oldest K790987 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations between
- 3 generations backK103208 Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011
- 2 generations backK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
- 1 generation backK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
- This deviceK193226 AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P. · 2020
- Descendant · cites it directly · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK243248 Inhance Intact™Depuy Ireland UC · 2024
- Descendant · 2 generations on · 0 of its ownK230831 INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE…Depuy Ireland UC · 2023
- Descendant · 2 generations on · 0 of its ownK223211 INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC · 2022
Show all 13 generations
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 6 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 5 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 4 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 3 generations backK103208 Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011
- 2 generations backK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
- 1 generation backK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
- This deviceK193226 AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P. · 2020
Most influential descendants
Showing 4 of 4 · See all- K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · cites it directly3descendants
- K243248Inhance Intact™Depuy Ireland UC · 2024 · 2 generations on0descendants
- K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC · 2023 · 2 generations on0descendants
- K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −12 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −9 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −6 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −5 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −4 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −3 | K103208 | Reverse Shoulder Prosthesis Monoblock Stem | Encore Medical L.P. | 2011 | — |
| −2 | K140904 | RSP Monoblock Stem with P2 Coating, Size 6 | Encore Medical L.P. | 2014 | — |
| −1 | K162024 | AltiVate Anatomic Shoulder System | Encore Medical L.P. | 2016 | 6 |
| 0 (this device) | K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | Encore Medical L.P. | 2020 | — |
| +1 | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +2 | K243248 | Inhance Intact™ | Depuy Ireland UC | 2024 | — |
| +2 | K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | 2023 | — |
| +2 | K223211 | INHANCETM Shoulder System – Humeral Stems and Stemless | Depuy Ireland UC | 2022 | — |
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 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 PKC? 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 PKC device
- #1 K240716 AETOS Shoulder System Stemless Humeral…score 22.2 · 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? (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 |
|---|---|---|---|
| * | K143552 | Simpliciti Shoulder SystemSummary page 4…Device Manufacturer 510(k) Number Simpliciti Shoulder System Tornier K143552 AltiVate Anatomic Shoulder System Encore Medical, L.P. K162024… | 2015 |
| * | K162024 | AltiVate Anatomic Shoulder SystemSummary page 4…impliciti Shoulder System Tornier K143552 AltiVate Anatomic Shoulder System Encore Medical, L.P. K162024 K193226 Page 2 of 2 Comparable Feat… | 2016 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203108 | Ignite Stemless Anatomic Shoulder System | 2021 | 3 |
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 29 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 31 of the 116 ancestors have a recall of any class.
- Of its descendants, K203108 (Ignite Orthopedics, LLC, 2021) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K143552.
How does its category compare?
All PKC devicesPKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PKC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKC
167in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PKC
86in 2025
MAUDE reports naming product code PKC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 1 | — | 1 | 8 |
| 2020 | 4 | 116 | 0 | 5 |
| 2021 | 2 | — | 0 | 14 |
| 2022 | 3 | 148 | 0 | 31 |
| 2023 | 1 | — | 0 | 46 |
| 2024 | 3 | 167 | 0 | 54 |
| 2025 | 1 | — | 0 | 86 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The AltiVate® Anatomic CS Shoulder is indicated for severely painful and/or disabled shoulder joint resulting from
osteoarthritis or traumatic arthritis.
The humeral components with a porous coated surface are indicated for uncemented (press-fit) applications. Glenoid
components are indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193226: AltiVate Anatomic Canal-Sparing (CS) Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193226
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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