510(k) · Cleared
Recalled · Class II · 2026Encore Reverse Shoulder Prosthesis
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 May 27, 2005 as substantially equivalent to K041066 (Encore Medical L.P., 2005) after a 30-day review. Its family tree reaches back 1 generation to 2005. 1 of the 250 devices in its family, counting itself, has a Class I recall. 248 later devices descend from it. It has been recalled 5 times.
- Decided
- May 27, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041066 (2005). 248 later devices descend from it, 19 citing it directly. 1 of the 250 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK041066 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
- This deviceK051075 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005
- Descendant · cites it directly · 201 of its ownK052086 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 · cites it directly · 175 of its ownK072804 Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007
- Descendant · cites it directly · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
Showing 5 of 248 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shouldercites it directly · 2008
Most influential descendants
Showing 5 of 248 · See all- K052086Encore Reverse Shoulder Prosthesis Humeral Stem AdapterEncore Medical, Inc. · 2005 · cites it directly201descendants
- 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
- K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007 · cites it directly175descendants
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · cites it directly172descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041066 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | 4 |
| 0 (this device) | K051075 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | — |
| +1 | 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 |
| +1 | K072804 | Comprehensive RS Shoulder System | Biomet Manufacturing Corp | 2007 | — |
| +1 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 1 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 7 | 0 |
| 2013 | 11 | 0 |
| 2014 | 8 | 0 |
| 2015 | 7 | 0 |
| 2016 | 8 | 0 |
| 2017 | 16 | 0 |
| 2018 | 11 | 0 |
| 2019 | 16 | 0 |
| 2020 | 18 | 0 |
| 2021 | 24 | 0 |
| 2022 | 19 | 0 |
| 2023 | 17 | 0 |
| 2024 | 19 | 0 |
| 2025 | 22 | 0 |
| 2026 | 25 | 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? (1)
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…uivalence The modified Encore Reverse Shoulder Prosthesis is similar in design, materials, and intended use to the previously cleared Encore Reverse Shoulder Prosthesis, K041066. 20 of 20 DEP… | 2005 |
What descends from it? (248)
See all 24819 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052086 | Encore Reverse Shoulder Prosthesis Humeral Stem Adapter | 2005 | 201 |
| K063569 | Equinoxe Reverse Shoulder System | 2007 | 190 |
| K072804 | Comprehensive RS Shoulder System | 2007 | 175 |
| K080642 | Comprehensive Reverse Shoulder Class I | 2008 | 172 |
| K092873 | Reverse Shoulder Prosthesis | 2009 | 125 |
| K110599 | Aequalis Ascend Modular Reverse Shoulder System | 2011 | 108 |
| K112069 | RSP Glenoid Baseplate Porous Coated | 2011 | 74 |
| K100741 | Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts… | 2010 | 65 |
| K131559 | Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides | 2013 | 35 |
| K132285 | Aequalis Reversed Shoulder Prosthesis | 2013 | 26 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2026 | Class II | Z-1460-2026 | Process control | Knee and Humeral socket implants contain incorrect labeling. |
| Oct 5, 2023 | Class II | Z-0625-2024 | Packaging process control | Mislabeling |
| Sep 25, 2023 | Class II | Z-0282-2024 | 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-2606-2023 | 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 |
| Apr 18, 2011 | Not classified | Z-2739-2011 | Nonconforming Material/Component | The device has the potential to not appropriately mate with the humeral stem. |
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 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 indicated 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051075: Encore Reverse Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051075
Report an extraction error
Are you the manufacturer?
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