510(k) · Cleared
Recalled · Class II · 2026Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012
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 Aug 2, 2010 as substantially equivalent to K041066 (Encore Medical L.P., 2005) and 2 other predicates after a 139-day review. Its family tree reaches back 3 generations to 2005. 65 later devices descend from it. It has been recalled once.
- Decided
- Aug 2, 2010
- Review
- 139 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K041066 (2005). 65 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK041066 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
- 2 generations backK051075 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
- 1 generation backK092873 Reverse Shoulder ProsthesisDjo Surgical · 2009
- This deviceK100741 Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder…Encore Medical L.P. · 2010
- Descendant · cites it directly · 59 of its ownK130048 Reverse Shoulder Prosthesis MonoblockEncore Medical L.P. · 2013
- Descendant · cites it directly · 55 of its ownK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
- Descendant · 2 generations on · 34 of its ownK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
- Descendant · cites it directly · 21 of its ownK141006 RSP Humeral Socket InsertDjo Global · 2014 · Recalled
- Descendant · 2 generations on · 20 of its ownK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P. · 2013 · cites it directly59descendants
- K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014 · cites it directly55descendants
- K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · 2 generations on34descendants
- K141006RSP Humeral Socket InsertDjo Global · 2014 · cites it directly21descendants
- K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2015 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K041066 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | 4 |
| −2 | K051075 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | 5 |
| −1 | K092873 | Reverse Shoulder Prosthesis | Djo Surgical | 2009 | — |
| 0 (this device) | K100741 | Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis… | Encore Medical L.P. | 2010 | — |
| +1 | K130048 | Reverse Shoulder Prosthesis Monoblock | Encore Medical L.P. | 2013 | — |
| +1 | K140904 | RSP Monoblock Stem with P2 Coating, Size 6 | Encore Medical L.P. | 2014 | — |
| +2 | K162024 | AltiVate Anatomic Shoulder System | Encore Medical L.P. | 2016 | 6 |
| +1 | K141006 | RSP Humeral Socket Insert | Djo Global | 2014 | 2 |
| +2 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 9 | 0 |
| 2026 | 9 | 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 PHX? 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? (3)
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 |
|---|---|---|---|
| * | K041066 | Encore Reverse Shoulder ProsthesisSummary page 4…834-6255 ‘ 9800 Metric Blvd Fax: (512) 834-6313 Austin, TX 78758 Email: [email protected] Product 519(k) Number, Clearance Date/ Classification Product Code K041066 - March 24, 2005 K051075 — May 27, 2005 Reverse® Shoulder Prosthesis K092873 — October 27, 2009 KWS Class 1! Product Code ' Regu… | 2005 |
| * | K051075 | Encore Reverse Shoulder ProsthesisSummary page 4…vd Fax: (512) 834-6313 Austin, TX 78758 Email: [email protected] Product 519(k) Number, Clearance Date/ Classification Product Code K041066 - March 24, 2005 K051075 — May 27, 2005 Reverse® Shoulder Prosthesis K092873 — October 27, 2009 KWS Class 1! Product Code ' Regulation and Classification… | 2005 |
| * | K092873 | Reverse Shoulder ProsthesisSummary page 4…[email protected] Product 519(k) Number, Clearance Date/ Classification Product Code K041066 - March 24, 2005 K051075 — May 27, 2005 Reverse® Shoulder Prosthesis K092873 — October 27, 2009 KWS Class 1! Product Code ' Regulation and Classification Name KWS Shoulder joint metal/polymer semi-constrain… | 2009 |
What descends from it? (65)
See all 657 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130048 | Reverse Shoulder Prosthesis Monoblock | 2013 | 59 |
| K140904 | RSP Monoblock Stem with P2 Coating, Size 6 | 2014 | 55 |
| K141006 | RSP Humeral Socket Insert | 2014 | 21 |
| K141990 | Encore Humeral Shoulder Stem | 2014 | 19 |
| K111061 | Reverse Shoulder Monoblock Prosthesis (RSP) | 2011 | 19 |
| K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small… | 2017 | 18 |
| K213459 | Glenoid Reconstruction System | 2022 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2026 | Class II | Z-1458-2026 | Process control | Knee and Humeral socket implants contain incorrect labeling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K130048 (Encore Medical L.P., 2013) has gone furthest, with 59 descendants of its own.
- 24 other devices also cite its predicate K041066.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
For treatment of patlents with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
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/K100741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100741: Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100741
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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