510(k) · Cleared
Recalled · Class II · 2023AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
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 Oct 30, 2017 as substantially equivalent to K141990 (Encore Medical L.P., 2014) and 5 other predicates after an 88-day review. Its family tree reaches back 15 generations to 1991. 1 of the 165 devices in its family, counting itself, has a Class I recall. 18 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 30, 2017
- Review
- 88 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 3
- Predicates
- 6
Its longest line of descent runs back 15 generations to K911686 (1991). 146 ancestors in all, the oldest K790987 (1979). 18 later devices descend from it, 7 citing it directly. 1 of the 165 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations between
- 3 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 1 generation backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- This deviceK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017
- Descendant · cites it directly · 15 of its ownK190290 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 · 2 generations on · 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
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 backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 8 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 7 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 6 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 5 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 4 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 3 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 1 generation backK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- This deviceK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder5 generations back · 2008
Most influential descendants
Showing 5 of 18 · See all- K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019 · cites it directly15descendants
- 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 · 2 generations on2descendants
- K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022 · cites it directly2descendants
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 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −8 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −7 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −6 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −5 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −4 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −3 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −2 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −1 | K141990 | Encore Humeral Shoulder Stem | Encore Medical L.P. | 2014 | 3 |
| 0 (this device) | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate… | Encore Medical L.P. | 2017 | — |
| +1 | 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 | — |
| +2 | 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 |
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 | 2 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (6)
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 6…nd hemi procedures All humeral stems are intended for cemented or cementless use. Predicate Devices: • Encore Humeral Shoulder Stem (now called AltiVate Reverse) - K141990 • Reverse® Shoulder Prosthesis Monoblock - K100741, K111061, K111735, K141006 • Zimmer Trabecular Metal Reverse – K052906… | 2014 |
| * | K100741 | Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts…Summary page 6…cemented or cementless use. Predicate Devices: • Encore Humeral Shoulder Stem (now called AltiVate Reverse) - K141990 • Reverse® Shoulder Prosthesis Monoblock - K100741, K111061, K111735, K141006 • Zimmer Trabecular Metal Reverse – K052906 Comparable Features to Predicate Device(s): The AltiV… | 2010 |
| * | K111061 | Reverse Shoulder Monoblock Prosthesis (RSP)Summary page 6…or cementless use. Predicate Devices: • Encore Humeral Shoulder Stem (now called AltiVate Reverse) - K141990 • Reverse® Shoulder Prosthesis Monoblock - K100741, K111061, K111735, K141006 • Zimmer Trabecular Metal Reverse – K052906 Comparable Features to Predicate Device(s): The AltiVate Rever… | 2011 |
| * | K111735 | Reverse Shoulder Prosthesis Monoblock Hemi AdapterSummary page 6…less use. Predicate Devices: • Encore Humeral Shoulder Stem (now called AltiVate Reverse) - K141990 • Reverse® Shoulder Prosthesis Monoblock - K100741, K111061, K111735, K141006 • Zimmer Trabecular Metal Reverse – K052906 Comparable Features to Predicate Device(s): The AltiVate Reverse Small… | 2011 |
| * | K141006 | RSP Humeral Socket InsertSummary page 6…Predicate Devices: • Encore Humeral Shoulder Stem (now called AltiVate Reverse) - K141990 • Reverse® Shoulder Prosthesis Monoblock - K100741, K111061, K111735, K141006 • Zimmer Trabecular Metal Reverse – K052906 Comparable Features to Predicate Device(s): The AltiVate Reverse Small Shell Sho… | 2014 |
| * | K052906 | Zimmer Trabecular Metal Reverse Shoulder SystemSummary page 6…er Stem (now called AltiVate Reverse) - K141990 • Reverse® Shoulder Prosthesis Monoblock - K100741, K111061, K111735, K141006 • Zimmer Trabecular Metal Reverse – K052906 Comparable Features to Predicate Device(s): The AltiVate Reverse Small Shell Shoulder line extension includes a diametrically re… | 2005 |
What descends from it? (18)
See all 187 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 |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | 2021 | 5 |
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | 2022 | 2 |
| K233712 | PRIMA Humeral System; PRIMA TT Glenoid | 2024 | 1 |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | 2022 | 1 |
| K202098 | GLOBAL UNITE™ Platform Shoulder System | 2020 | 1 |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA… | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2023 | Class II | Z-0281-2024 | Labeling Change Control | Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery. |
| Aug 4, 2023 | Class II | Z-2607-2023 | Nonconforming Material/Component | Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery |
| Aug 31, 2020 | Class II | Z-0117-2021 | Labeling False and Misleading | Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. |
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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 41 of the 146 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K190290 (Encore Medical L.P., 2019) has gone furthest, with 15 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. 2017, 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?
Indications for AltiVate™ Stem: Anatomic Total Shoulder Indications: The AltiVate™ Shoulder Prosthesis 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…
Read the full statement (324 words)
Indications for AltiVate™ Stem:
Anatomic Total Shoulder Indications:
The AltiVate™ Shoulder Prosthesis 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™ Shoulder Prosthesis 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™ Shoulder Prosthesis 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/K172351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172351: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172351
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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