510(k) · Cleared
Recalled · Class II · 2018Encore Humeral Shoulder Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Nov 7, 2014 as substantially equivalent to K100741 (Encore Medical L.P., 2010) and 9 other predicates after a 108-day review. Its family tree reaches back 14 generations to 1991. 1 of the 135 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 7, 2014
- Review
- 108 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 3
- Predicates
- 10
Its longest line of descent runs back 14 generations to K911686 (1991). 115 ancestors in all, the oldest K790987 (1979). 19 later devices descend from it, 3 citing it directly. 1 of the 135 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- This deviceK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014
- Descendant · cites it directly · 18 of its ownK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- 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
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 backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- This deviceK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014
Showing 5 of 19 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 19 · See all- K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P. · 2017 · cites it directly18descendants
- 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
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 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −7 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −6 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −5 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −4 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −3 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −2 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −1 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| 0 (this device) | K141990 | Encore Humeral Shoulder Stem | Encore Medical L.P. | 2014 | — |
| +1 | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate… | Encore Medical L.P. | 2017 | 3 |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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 PHX device
- #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K100741 | Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts…Summary page 6…mpts for anatomic and hemi procedures All humeral stems are intended for cemented or cementless use. Predicate Devices: Reverse® Shoulder Prosthesis Monoblock – K100741, K111735, K130048, K103208, K140904 Encore® Shoulder System – K080402 Foundation Shoulder System - K950651 E… | 2010 |
| * | K111735 | Reverse Shoulder Prosthesis Monoblock Hemi AdapterSummary page 6…anatomic and hemi procedures All humeral stems are intended for cemented or cementless use. Predicate Devices: Reverse® Shoulder Prosthesis Monoblock – K100741, K111735, K130048, K103208, K140904 Encore® Shoulder System – K080402 Foundation Shoulder System - K950651 Encore® He… | 2011 |
| * | K130048 | Reverse Shoulder Prosthesis MonoblockSummary page 6…and hemi procedures All humeral stems are intended for cemented or cementless use. Predicate Devices: Reverse® Shoulder Prosthesis Monoblock – K100741, K111735, K130048, K103208, K140904 Encore® Shoulder System – K080402 Foundation Shoulder System - K950651 Encore® Hemi Should… | 2013 |
| * | K103208 | Reverse Shoulder Prosthesis Monoblock StemSummary page 6…procedures All humeral stems are intended for cemented or cementless use. Predicate Devices: Reverse® Shoulder Prosthesis Monoblock – K100741, K111735, K130048, K103208, K140904 Encore® Shoulder System – K080402 Foundation Shoulder System - K950651 Encore® Hemi Shoulder – K950… | 2011 |
| * | K140904 | RSP Monoblock Stem with P2 Coating, Size 6Summary page 6…s All humeral stems are intended for cemented or cementless use. Predicate Devices: Reverse® Shoulder Prosthesis Monoblock – K100741, K111735, K130048, K103208, K140904 Encore® Shoulder System – K080402 Foundation Shoulder System - K950651 Encore® Hemi Shoulder – K950594 … | 2014 |
| * | K080402 | Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model…Summary page 6…ented or cementless use. Predicate Devices: Reverse® Shoulder Prosthesis Monoblock – K100741, K111735, K130048, K103208, K140904 Encore® Shoulder System – K080402 Foundation Shoulder System - K950651 Encore® Hemi Shoulder – K950594 Torneir Aequalis® Reversed Fracture Sho… | 2008 |
| * | K950651 | Total Shoulder ProsthesisSummary page 6… Reverse® Shoulder Prosthesis Monoblock – K100741, K111735, K130048, K103208, K140904 Encore® Shoulder System – K080402 Foundation Shoulder System - K950651 Encore® Hemi Shoulder – K950594 Torneir Aequalis® Reversed Fracture Shoulder Prosthesis – K082120 Tornier Ae… | 1995 |
| * | K950594 | Hemi-Shoulder ProsthesisSummary page 6…noblock – K100741, K111735, K130048, K103208, K140904 Encore® Shoulder System – K080402 Foundation Shoulder System - K950651 Encore® Hemi Shoulder – K950594 Torneir Aequalis® Reversed Fracture Shoulder Prosthesis – K082120 Tornier Aequalis® Flex Shoulder System – K122698… | 1995 |
| * | K082120 | Aequalis Reversed Fracture Shoulder ProthesisSummary page 6…lder System – K080402 Foundation Shoulder System - K950651 Encore® Hemi Shoulder – K950594 Torneir Aequalis® Reversed Fracture Shoulder Prosthesis – K082120 Tornier Aequalis® Flex Shoulder System – K122698 Comparable Features to Predicate Device(s): Features comparable to predi… | 2008 |
| * | K122698 | Aequalis Ascend Flex Shoulder SystemSummary page 6…- K950651 Encore® Hemi Shoulder – K950594 Torneir Aequalis® Reversed Fracture Shoulder Prosthesis – K082120 Tornier Aequalis® Flex Shoulder System – K122698 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same material substrate, same p… | 2013 |
What descends from it? (19)
See all 193 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2018 | Class II | Z-1241-2018 | Device Design | Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial. |
| Dec 8, 2015 | Class II | Z-0626-2016 | Nonconforming Material/Component | The trial shell mating feature on the broach is undersized. |
| Sep 15, 2015 | Class II | Z-0131-2016 | Device Design | Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw. |
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 23 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 28 of the 115 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K172351 (Encore Medical L.P., 2017) has gone furthest, with 18 descendants of its own.
- 6 other devices also cite its predicate K100741.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, 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 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
Anatomic Total Shoulder Indications: The Encore® 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…
Read the full statement (300 words)
Anatomic Total Shoulder Indications:
The Encore® 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 Encore® 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 Encore® 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 as stated in the FDA summary.
https://510kreport.com/device/K141990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141990: Encore Humeral Shoulder Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141990
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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