510(k) · Cleared
Recalled · Class II · 2021AltiVate Anatomic Shoulder System
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 Nov 21, 2016 as substantially equivalent to K080402 (Encore Medical L.P., 2008) and 3 other predicates after a 122-day review. Its family tree reaches back 12 generations to 1991. 34 later devices descend from it. It has been recalled 6 times.
- Decided
- Nov 21, 2016
- Review
- 122 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 6
- Predicates
- 4
Its longest line of descent runs back 12 generations to K911686 (1991). 110 ancestors in all, the oldest K790987 (1979). 34 later devices descend from it, 8 citing it directly.
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations between
- 3 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 2 generations backK103208 Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011
- 1 generation backK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
- This deviceK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016
- Descendant · cites it directly · 15 of its ownK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
- Descendant · cites it directly · 13 of its ownK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 2 generations on · 9 of its ownK212737 INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022
- Descendant · 2 generations on · 5 of its ownK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK193226 AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P. · 2020
Show all 12 generations
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 10 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 9 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 8 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 5 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 4 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 3 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 2 generations backK103208 Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011
- 1 generation backK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
- This deviceK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019 · cites it directly15descendants
- K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · cites it directly13descendants
- K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022 · 2 generations on9descendants
- K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 2 generations on5descendants
- K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P. · 2020 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −11 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −8 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −5 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −4 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −3 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −2 | K103208 | Reverse Shoulder Prosthesis Monoblock Stem | Encore Medical L.P. | 2011 | — |
| −1 | K140904 | RSP Monoblock Stem with P2 Coating, Size 6 | Encore Medical L.P. | 2014 | — |
| 0 (this device) | K162024 | AltiVate Anatomic Shoulder System | Encore Medical L.P. | 2016 | — |
| +1 | K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. | 2019 | — |
| +1 | K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +2 | K212737 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | 2022 | — |
| +2 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| +1 | K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | Encore Medical L.P. | 2020 | — |
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 | 6 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K080402 | Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model…Summary page 5…ther cemented or uncemented applications. Glenoid components are indicated for cemented use only. Predicate Devices: Encore® Shoulder System (now called Turon) - K080402, K123982 RSP Monoblock Stem with P2 - K140904 Tornier™ Aequalis Ascend Flex – K113413 Comparable Features to Predi… | 2008 |
| * | K123982 | Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Summary page 5…nted or uncemented applications. Glenoid components are indicated for cemented use only. Predicate Devices: Encore® Shoulder System (now called Turon) - K080402, K123982 RSP Monoblock Stem with P2 - K140904 Tornier™ Aequalis Ascend Flex – K113413 Comparable Features to Predicate Devi… | 2013 |
| * | K140904 | RSP Monoblock Stem with P2 Coating, Size 6Summary page 5…ponents are indicated for cemented use only. Predicate Devices: Encore® Shoulder System (now called Turon) - K080402, K123982 RSP Monoblock Stem with P2 - K140904 Tornier™ Aequalis Ascend Flex – K113413 Comparable Features to Predicate Device(s): This device is comparable to the pred… | 2014 |
| * | K113413 | Ascend Shoulder SystemSummary page 5…redicate Devices: Encore® Shoulder System (now called Turon) - K080402, K123982 RSP Monoblock Stem with P2 - K140904 Tornier™ Aequalis Ascend Flex – K113413 Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in implant material, basic design… | 2012 |
What descends from it? (34)
See all 348 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190290 | AltiVate Reverse Humeral Stem, 48mm | 2019 | 15 |
| K202716 | Ignite Anatomic Shoulder System | 2021 | 13 |
| K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | 2020 | 4 |
| K173073 | AltiVate Anatomic to Reverse Conversion Module | 2017 | 3 |
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | 2022 | 2 |
| K203026 | AltiVate® Anatomic Pegged Glenoid with Markers | 2020 | 2 |
| K213387 | AltiVate® Anatomic Shoulder AG e+™ with Markers | 2022 | 1 |
| K202098 | GLOBAL UNITE™ Platform Shoulder System | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2021 | Class II | Z-2331-2021 | Process change control | Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery. |
| Jan 29, 2018 | Class II | Z-1258-2018 | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the… |
| Jan 29, 2018 | Class II | Z-1260-2018 | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the… |
| Jan 29, 2018 | Class II | Z-1256-2018 | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the… |
| Jan 29, 2018 | Class II | Z-1257-2018 | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the… |
| Jan 29, 2018 | Class II | Z-1259-2018 | Device Design | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 29 of the 110 ancestors have a recall of any class.
- Of its descendants, K190290 (Encore Medical L.P., 2019) has gone furthest, with 15 descendants of its own.
- 6 other devices also cite its predicate K080402.
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. 2016, 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 (191 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 AltiVate Anatomic™ Shoulder System is a hemiarthroplasty shoulder replacement for patients with a functional deltoid muscle 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
• Rotator cuff tear arthropathy
• 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/K162024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162024: AltiVate Anatomic Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162024
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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