510(k) · Cleared
ClearedAltiVate Reverse Humeral Stem, 48mm
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 Apr 26, 2019 as substantially equivalent to K141990 (Encore Medical L.P., 2014) and 4 other predicates after a 74-day review. Its family tree reaches back 16 generations to 1991. 1 of the 165 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- Apr 26, 2019
- Review
- 74 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K911686 (1991). 149 ancestors in all, the oldest K790987 (1979). 15 later devices descend from it, 5 citing it directly. 1 of the 165 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations between
- 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- 1 generation backK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- This deviceK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
- Descendant · cites it directly · 5 of its ownK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK211991 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK213349 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK212800 PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022 · Recalled
- Descendant · cites it directly · 2 of its ownK202024 ARROW Short Stem Humeral SystemFH Industrie · 2021
Show all 16 generations
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 15 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 14 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 13 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 12 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 9 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 8 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 7 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 6 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 5 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 4 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- 1 generation backK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- This deviceK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder4 generations back · 2008
Most influential descendants
Showing 5 of 15 · See all- K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · cites it directly5descendants
- K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 2 generations on3descendants
- K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2022 · cites it directly2descendants
- K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022 · cites it directly2descendants
- K202024ARROW Short Stem Humeral SystemFH Industrie · 2021 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −15 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −12 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −9 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −8 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −7 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −6 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −5 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −4 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −3 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −2 | K141990 | Encore Humeral Shoulder Stem | Encore Medical L.P. | 2014 | 3 |
| −1 | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate… | Encore Medical L.P. | 2017 | 3 |
| 0 (this device) | K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. | 2019 | — |
| +1 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| +2 | K211991 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| +1 | K213349 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2022 | — |
| +1 | K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Lima Corporate S.P.A. | 2022 | 2 |
| +1 | K202024 | ARROW Short Stem Humeral System | FH Industrie | 2021 | — |
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 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 8 | 0 |
| 2006 | 9 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 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? (5)
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 |
|---|---|---|---|
| * | K141990 | Encore Humeral Shoulder StemSummary page 7…or cementless use. Predicate Devices: K190290 Page 3 of 3 x AltiVate Reverse® Humeral Stem, DJO Surgical – K141990 x AltiVate Anatomic® Shoulder System, DJO Surgical – K162024 x AltiVate Reverse® Small Shell, DJO Surgical – K172351 x Aequalis A… | 2014 |
| * | K162024 | AltiVate Anatomic Shoulder SystemSummary page 7…K190290 Page 3 of 3 x AltiVate Reverse® Humeral Stem, DJO Surgical – K141990 x AltiVate Anatomic® Shoulder System, DJO Surgical – K162024 x AltiVate Reverse® Small Shell, DJO Surgical – K172351 x Aequalis Ascend Flex Shoulder System, Wright/Tornier – K122698 x Aequal… | 2016 |
| * | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Summary page 7…f 3 x AltiVate Reverse® Humeral Stem, DJO Surgical – K141990 x AltiVate Anatomic® Shoulder System, DJO Surgical – K162024 x AltiVate Reverse® Small Shell, DJO Surgical – K172351 x Aequalis Ascend Flex Shoulder System, Wright/Tornier – K122698 x Aequalis, Wright/Tornier - K113413 Comparable Features to Pre… | 2017 |
| * | K122698 | Aequalis Ascend Flex Shoulder SystemSummary page 7…tiVate Anatomic® Shoulder System, DJO Surgical – K162024 x AltiVate Reverse® Small Shell, DJO Surgical – K172351 x Aequalis Ascend Flex Shoulder System, Wright/Tornier – K122698 x Aequalis, Wright/Tornier - K113413 Comparable Features to Predicate Device(s): Features comparable to predicate devices includ… | 2013 |
| * | K113413 | Ascend Shoulder SystemSummary page 7…Surgical – K162024 x AltiVate Reverse® Small Shell, DJO Surgical – K172351 x Aequalis Ascend Flex Shoulder System, Wright/Tornier – K122698 x Aequalis, Wright/Tornier - K113413 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications for use, same… | 2012 |
What descends from it? (15)
See all 155 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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 43 of the 149 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K202611 (Catalyst Orthoscience, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K141990.
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. 2019, 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?
Anatomic Total Shoulder Indications: The AltiVate Reverse Humeral Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: * Noninflammatory degenerative joint disease including osteoarthritis; * Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis; * Post-traumatic arthritis of the glenohumeral joint; * Avascular necrosis of the humeral head with and without…
Read the full statement (320 words)
Anatomic Total Shoulder Indications:
The AltiVate Reverse Humeral Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
* Noninflammatory degenerative joint disease including osteoarthritis;
* Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
* Post-traumatic arthritis of the glenohumeral joint;
* Avascular necrosis of the humeral head with and without involvement of the glenoid;
* Correction of functional deformity
The all-poly glenoid is intended for cemented use
Hemi Shoulder Indications:
The AltiVate Reverse Humeral Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:
* Noninflammatory degenerative joint disease including osteoarthritis;
* Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
* Post-traumatic arthritis of the glenohumeral joint;
* Avascular necrosis of the humeral head with and without involvement of the glenoid;
* Correction of functional deformity;
* Rotator cuff tear arthropathy;
* Humeral fracture.
* Failed previous shoulder surgery
Reverse Total Shoulder Indications:
The AltiVate Reverse Humeral Stem is as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
* Severe arthropathy with a grossly deficient rotator cuff;
* Previously failed joint replacement with a grossly deficient rotator cuff;
* Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
* Bone defect in proximal humerus;
* Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
* Inflammatory arthritis including rheumatoid arthritis;
* Correction of functional deformity.
The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures
All humeral stems are intended for cemented or cementless use.
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/K190290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190290: AltiVate Reverse Humeral Stem, 48mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190290
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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