510(k) · Cleared
ClearedRSP Monoblock Stem with P2 Coating, Size 6
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 6, 2014 as substantially equivalent to K100741 (Encore Medical L.P., 2010) and 4 other predicates after a 27-day review. Its family tree reaches back 11 generations to 1991. 55 later devices descend from it.
- Decided
- May 6, 2014
- Review
- 27 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K911686 (1991). 63 ancestors in all, the oldest K790987 (1979). 55 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations between
- 3 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 2 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 1 generation backK103208 Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011
- This deviceK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
- Descendant · cites it directly · 34 of its ownK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
- Descendant · cites it directly · 20 of its ownK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- Descendant · cites it directly · 19 of its ownK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- Descendant · 2 generations on · 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
Show all 11 generations
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 9 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 8 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 7 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 4 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 3 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 2 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 1 generation backK103208 Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011
- This deviceK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · cites it directly34descendants
- K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2015 · cites it directly20descendants
- K141990Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · cites it directly19descendants
- K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P. · 2017 · 2 generations on18descendants
- K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −10 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −7 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −4 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −3 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −2 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −1 | K103208 | Reverse Shoulder Prosthesis Monoblock Stem | Encore Medical L.P. | 2011 | — |
| 0 (this device) | K140904 | RSP Monoblock Stem with P2 Coating, Size 6 | Encore Medical L.P. | 2014 | — |
| +1 | K162024 | AltiVate Anatomic Shoulder System | Encore Medical L.P. | 2016 | 6 |
| +1 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| +1 | K141990 | Encore Humeral Shoulder Stem | Encore Medical L.P. | 2014 | 3 |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 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? (5)
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 |
|---|---|---|---|
| * | K100741 | Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts…Summary page 4…on with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use. Predicate Devices: =~ RSP Monoblock Humeral Stem, DJO Surgical K100741, K103208, K130048 RSP Baseplate with Porous Coating, DJO Surgical K112069 Reverse Shoulder Prosthesis — DJO Surgical K041066 Com… | 2010 |
| * | K103208 | Reverse Shoulder Prosthesis Monoblock StemSummary page 4…he addition of screws for fixation. The humeral stem is intended for cemented or cementless use. Predicate Devices: =~ RSP Monoblock Humeral Stem, DJO Surgical K100741, K103208, K130048 RSP Baseplate with Porous Coating, DJO Surgical K112069 Reverse Shoulder Prosthesis — DJO Surgical K041066 Comparable F… | 2011 |
| * | K130048 | Reverse Shoulder Prosthesis MonoblockSummary page 4…on of screws for fixation. The humeral stem is intended for cemented or cementless use. Predicate Devices: =~ RSP Monoblock Humeral Stem, DJO Surgical K100741, K103208, K130048 RSP Baseplate with Porous Coating, DJO Surgical K112069 Reverse Shoulder Prosthesis — DJO Surgical K041066 Comparable Features t… | 2013 |
| * | K112069 | RSP Glenoid Baseplate Porous CoatedSummary page 4…for cemented or cementless use. Predicate Devices: =~ RSP Monoblock Humeral Stem, DJO Surgical K100741, K103208, K130048 RSP Baseplate with Porous Coating, DJO Surgical K112069 Reverse Shoulder Prosthesis — DJO Surgical K041066 Comparable Features to Predicate Device(s): This device is comparable to the… | 2011 |
| * | K041066 | Encore Reverse Shoulder ProsthesisSummary page 4…=~ RSP Monoblock Humeral Stem, DJO Surgical K100741, K103208, K130048 RSP Baseplate with Porous Coating, DJO Surgical K112069 Reverse Shoulder Prosthesis — DJO Surgical K041066 Comparable Features to Predicate Device(s): This device is comparable to the current RSP Monoblock Stem in indications, materia… | 2005 |
What descends from it? (55)
See all 553 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 15 of the 63 ancestors have a recall of any class.
- Of its descendants, K162024 (Encore Medical L.P., 2016) has gone furthest, with 34 descendants of its own.
- 6 other devices also cite its predicate K100741.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Prosthesis Monoblock 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…
Read the full statement (118 words)
The Reverse® Shoulder Prosthesis Monoblock 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. (For cemented implantation only)
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 or cementless use.
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/K140904 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140904: RSP Monoblock Stem with P2 Coating, Size 6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140904
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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