510(k) · Cleared
ClearedEncore Reverse Shoulder Prosthesis Humeral Stem Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Aug 31, 2005 as substantially equivalent to K041066 (Encore Medical L.P., 2005) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 2005. 1 of the 204 devices in its family, counting itself, has a Class I recall. 201 later devices descend from it.
- Decided
- Aug 31, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K041066 (2005). 201 later devices descend from it, 2 citing it directly. 1 of the 204 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK041066 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
- 1 generation backK051075 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
- This deviceK052086 Encore Reverse Shoulder Prosthesis Humeral Stem AdapterEncore Medical, Inc. · 2005
- Descendant · cites it directly · 190 of its ownK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 177 of its ownK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- Descendant · 3 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 4 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
Showing 5 of 201 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations on · 2008
Most influential descendants
Showing 5 of 201 · See all- K063569Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · cites it directly190descendants
- K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc. · 2008 · 2 generations on177descendants
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 2 generations on172descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on108descendants
- K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 4 generations on97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041066 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | 4 |
| −1 | K051075 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | 5 |
| 0 (this device) | K052086 | Encore Reverse Shoulder Prosthesis Humeral Stem Adapter | Encore Medical, Inc. | 2005 | — |
| +1 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| +2 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| +2 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| +3 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +4 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 1 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 10 | 0 |
| 2014 | 8 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 11 | 0 |
| 2019 | 14 | 0 |
| 2020 | 16 | 0 |
| 2021 | 21 | 0 |
| 2022 | 17 | 0 |
| 2023 | 14 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 18 | 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? (2)
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 1…ecial 510(k) submission. Substantial Equivalence The modified Encore RSP is similar in design, materials, and intended use to the previously cleared Encore RSP devices, K041066 and K051075. 13 of 13 === Page… | 2005 |
| * | K051075 | Encore Reverse Shoulder ProsthesisSummary page 1…submission. Substantial Equivalence The modified Encore RSP is similar in design, materials, and intended use to the previously cleared Encore RSP devices, K041066 and K051075. 13 of 13 DEP… | 2005 |
What descends from it? (201)
See all 2012 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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 0 years and passes through 2 companies; a new generation was cleared every 3 months on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K063569 (Exactech, Inc., 2007) has gone furthest, with 190 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.
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?
The Encore Reverse Shoulder Prosthesis (RSP) is intended for use in patients 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…
Read the full statement (172 words)
The Encore Reverse Shoulder Prosthesis (RSP) is intended for use in patients 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.
During primary surgery, after the humerus is prepared for the RSP humeral stem, if the glenoid bone stock appears "insufficient' to bear the load of the glenoid baseplate, a RSP humeral stem adapter can be used to convert the RSP humeral stem to a hemiarthroplasty prosthesis.
During revision surgery of an RSP, if the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device; a RSP Humeral Stem Adapter is used to convert the RSP device to a hemiarthroplasty prosthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052086 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052086: Encore Reverse Shoulder Prosthesis Humeral Stem Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052086
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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