510(k) · Cleared
ClearedReverse Shoulder Monoblock Prosthesis (RSP)
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 Jul 20, 2011 as substantially equivalent to K041066 (Encore Medical L.P., 2005) and 2 other predicates after a 93-day review. Its family tree reaches back 4 generations to 2005. 19 later devices descend from it.
- Decided
- Jul 20, 2011
- Review
- 93 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K041066 (2005). 19 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK041066 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
- 3 generations backK051075 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
- 2 generations backK092873 Reverse Shoulder ProsthesisDjo Surgical · 2009
- 1 generation backK100741 Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder…Encore Medical L.P. · 2010 · Recalled
- This deviceK111061 Reverse Shoulder Monoblock Prosthesis (RSP)Encore Medical L.P. · 2011
- Descendant · cites it directly · 18 of its ownK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- Descendant · 2 generations on · 15 of its ownK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
- Descendant · 2 generations on · 5 of its ownK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK211991 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK213349 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2022
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
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 · 2 generations on15descendants
- K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 2 generations on5descendants
- K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 3 generations on3descendants
- K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K041066 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | 4 |
| −3 | K051075 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | 5 |
| −2 | K092873 | Reverse Shoulder Prosthesis | Djo Surgical | 2009 | — |
| −1 | K100741 | Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis… | Encore Medical L.P. | 2010 | 1 |
| 0 (this device) | K111061 | Reverse Shoulder Monoblock Prosthesis (RSP) | Encore Medical L.P. | 2011 | — |
| +1 | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate… | Encore Medical L.P. | 2017 | 3 |
| +2 | K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. | 2019 | — |
| +2 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| +3 | K211991 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| +3 | K213349 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2022 | — |
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.
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…ication with the addition of screws for fixation. The humeral stem is intended for cemented use only. ‘ ' Predicate Device: o DJO Surgical Reverse Shoulder Prosthesis — K041066, K051075, K 100741 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design… | 2005 |
| * | K051075 | Encore Reverse Shoulder ProsthesisSummary page 4…ith the addition of screws for fixation. The humeral stem is intended for cemented use only. ‘ ' Predicate Device: o DJO Surgical Reverse Shoulder Prosthesis — K041066, K051075, K 100741 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features,… | 2005 |
| * | K100741 | Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts…Summary page 4…cation Name KWS Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3660 Description: This is a modification to the RSP Monoblock Stem cleared under K100741. The cleared RSP Monoblock Prosthesis system consists of a monoblock humeral stem with socket, humeral socket inserts, glenoid he… | 2010 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small… | 2017 | 18 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K172351 (Encore Medical L.P., 2017) has gone furthest, with 18 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. 2011, 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?
The Reverse Shoulder Monoblock Prosthesis is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint: In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.…
Read the full statement (112 words)
The Reverse Shoulder Monoblock Prosthesis is indicated for patients with a functional deltoid muscle
with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint
replacement with a grossly deficient rotator cuff shoulder joint:
In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder,
including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.
In cases of bone defect in proximal humerus.
The patient’s joint must be anatomically and structurally suited to receive the selected implant(s).
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/K111061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111061: Reverse Shoulder Monoblock Prosthesis (RSP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111061
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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