510(k) · Cleared
Recalled · Class II · 2023Encore 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 Mar 24, 2005 after a 335-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 of the 304 devices in its family, counting itself, has a Class I recall. 303 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 24, 2005
- Review
- 335 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 4
- Predicates
- 1
303 later devices descend from it, 25 citing it directly. 1 of the 304 devices in this family, counting this one, has a Class I recall.
- This deviceK041066 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005
- Descendant · cites it directly · 248 of its ownK051075 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
- Descendant · cites it directly · 239 of its ownK053274 Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · Recalled
- Descendant · cites it directly · 216 of its ownK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 207 of its ownK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- Descendant · cites it directly · 201 of its ownK052086 Encore Reverse Shoulder Prosthesis Humeral Stem AdapterEncore Medical, Inc. · 2005
Showing 5 of 303 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 303 · See all- K051075Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · cites it directly248descendants
- K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · cites it directly239descendants
- K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · cites it directly216descendants
- K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · 2 generations on207descendants
- K052086Encore Reverse Shoulder Prosthesis Humeral Stem AdapterEncore Medical, Inc. · 2005 · cites it directly201descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041066 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | — |
| +1 | K051075 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | 5 |
| +1 | K053274 | Anatomical Shoulder Inverse/Reverse | Zimmer GmbH | 2006 | 3 |
| +1 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| +2 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| +1 | K052086 | Encore Reverse Shoulder Prosthesis Humeral Stem Adapter | Encore Medical, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 1 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 13 | 0 |
| 2012 | 14 | 0 |
| 2013 | 15 | 0 |
| 2014 | 14 | 0 |
| 2015 | 8 | 0 |
| 2016 | 12 | 0 |
| 2017 | 19 | 0 |
| 2018 | 17 | 0 |
| 2019 | 17 | 0 |
| 2020 | 21 | 0 |
| 2021 | 26 | 0 |
| 2022 | 21 | 0 |
| 2023 | 18 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K023147 | FDA’s K023147 is Analog Multiplexed Cable Telemetry (Amt) Electromyograph, Models Amt-16, Amt-8… Our reading of the summary gave K023147, FDA’s number for Analog Multiplexed Cable Telemetry (Amt) Electromyograph… (Bortec Biomedical, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “DePuy Delta Shoulder”. Kept off the family tree. Summary page 1…on-locking and/or 5.0mm locking and non-locking) for additional fixation. Substantial Equivalence The Encore Reverse Shoulder is equivalent to the DePuy Delta Shoulder (K0231478). Public Health Service DEPA… | 2002 |
What descends from it? (303)
See all 30325 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051075 | Encore Reverse Shoulder Prosthesis | 2005 | 248 |
| K053274 | Anatomical Shoulder Inverse/Reverse | 2006 | 239 |
| K052906 | Zimmer Trabecular Metal Reverse Shoulder System | 2005 | 216 |
| 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 |
| K112069 | RSP Glenoid Baseplate Porous Coated | 2011 | 74 |
| K100741 | Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts… | 2010 | 65 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2023 | Class II | Z-0098-2024 | Mixed-up of materials/components | Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation. |
| Aug 8, 2007 | Not classified | Z-0184-2008 | Other | Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa. |
| Aug 8, 2007 | Not classified | Z-0185-2008 | Other | Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa. |
| Jul 28, 2005 | Not classified | Z-1566-05 | Other | Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit. |
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?
- Of its descendants, K051075 (Encore Medical L.P., 2005) has gone furthest, with 248 descendants of its own.
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 Reverse Shoulder 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/K041066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041066: Encore Reverse Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041066
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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