510(k) · Cleared
ClearedRSP Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining Screw
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, 2014 as substantially equivalent to K041066 (Encore Medical L.P., 2005) and 1 other predicate after a 385-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Mar 24, 2014
- Review
- 385 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K041066 (2005). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK041066 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
- This deviceK130550 RSP Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining ScrewEncore Medical L.P. · 2014
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) | K130550 | RSP Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining Screw | Encore Medical L.P. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (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 4…aseplate. The RSP Modular Glenoid Baseplate is a multiple piece construct as opposed to a single piece construct as the predicate Reverse Shoulder Prosthesis Baseplate (K041066). The RSP Modular Glenoid Baseplate is fabricated from wrought/forged Ti-6A 1-4V that conforms to ASTM F136. The bottom surface… | 2005 |
| * | K080402 | Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model…Summary page 4…additional fixation. The RSP Modular Glenoid Baseplate female taper and male taper of the adapter have geometry identical to those used in the predicate Turon Shoulder (K080402). There are no changes to sterilization, packaging, indications or intended use. Indications for Use: Indicated for use in pat… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 2 of the 2 ancestors have a recall of any class.
- 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. 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?
Indicated for usc in patients with a grossly rotator cuff deficient shoulder joint with scvere arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The paticnt’s joint must be anatomically and structurally suited to receive the selected implani(s), and a functional deltoid muscle is necessury to usc the device. The glenoid baseplate is intended for ccmentless 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/K130550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130550: RSP Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130550
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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