510(k) · Cleared
ClearedReverse Shoulder Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Djo Surgical · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Oct 27, 2009 as substantially equivalent to K041066 (Encore Medical L.P., 2005) and 1 other predicate after a 39-day review. Its family tree reaches back 2 generations to 2005. 125 later devices descend from it.
- Decided
- Oct 27, 2009
- Review
- 39 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K041066 (2005). 125 later devices descend from it, 11 citing it directly.
- Root · 2 generations backK041066 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
- 1 generation backK051075 Encore Reverse Shoulder ProsthesisEncore Medical L.P. · 2005 · Recalled
- This deviceK092873 Reverse Shoulder ProsthesisDjo Surgical · 2009
- Descendant · cites it directly · 74 of its ownK112069 RSP Glenoid Baseplate Porous CoatedEncore Medical L.P. · 2011 · Recalled
- Descendant · cites it directly · 65 of its ownK100741 Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder…Encore Medical L.P. · 2010 · Recalled
- Descendant · 2 generations on · 59 of its ownK130048 Reverse Shoulder Prosthesis MonoblockEncore Medical L.P. · 2013
- Descendant · 2 generations on · 55 of its ownK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
- Descendant · cites it directly · 35 of its ownK131559 Match Point System (TM), Surgicase Connect, Match Point System (TM)…Materialise NV · 2013
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 125 · See all- K112069RSP Glenoid Baseplate Porous CoatedEncore Medical L.P. · 2011 · cites it directly74descendants
- K100741Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts…Encore Medical L.P. · 2010 · cites it directly65descendants
- K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P. · 2013 · 2 generations on59descendants
- K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014 · 2 generations on55descendants
- K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV · 2013 · cites it directly35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041066 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | 4 |
| −1 | K051075 | Encore Reverse Shoulder Prosthesis | Encore Medical L.P. | 2005 | 5 |
| 0 (this device) | K092873 | Reverse Shoulder Prosthesis | Djo Surgical | 2009 | — |
| +1 | K112069 | RSP Glenoid Baseplate Porous Coated | Encore Medical L.P. | 2011 | 1 |
| +1 | K100741 | Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis… | Encore Medical L.P. | 2010 | 1 |
| +2 | K130048 | Reverse Shoulder Prosthesis Monoblock | Encore Medical L.P. | 2013 | — |
| +2 | K140904 | RSP Monoblock Stem with P2 Coating, Size 6 | Encore Medical L.P. | 2014 | — |
| +1 | K131559 | Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides | Materialise NV | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 11 | 0 |
| 2022 | 12 | 0 |
| 2023 | 11 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 0 |
| 2026 | 17 | 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…2) 834-6255 9800 Metric Blvd Fax: (512) 834-6313 Austin, TX 78758 Email: [email protected] Product 510(k) Number, Clearance Date/ Classification Product Code K041066 — March 24, 2005 Reverse® Shoulder Prosthesis K051075 — May 27, 2005 KWS Class II : Product Code Regulation and Classification Na… | 2005 |
| * | K051075 | Encore Reverse Shoulder ProsthesisSummary page 4…n, TX 78758 Email: [email protected] Product 510(k) Number, Clearance Date/ Classification Product Code K041066 — March 24, 2005 Reverse® Shoulder Prosthesis K051075 — May 27, 2005 KWS Class II : Product Code Regulation and Classification Name KWS Shoulder joint metal/polymer semi-constrained p… | 2005 |
What descends from it? (125)
See all 12511 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K141006 | RSP Humeral Socket Insert | 2014 | 21 |
| K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | 2015 | 20 |
| K233481 | AltiVate Reverse® Glenoid | 2024 | 4 |
| K173073 | AltiVate Anatomic to Reverse Conversion Module | 2017 | 3 |
| K252567 | AltiVate Reverse® ADLC Glenosphere | 2026 | 0 |
| K201905 | SMR 140° Reverse Humeral Body | 2020 | 0 |
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 4 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K112069 (Encore Medical L.P., 2011) has gone furthest, with 74 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. 2009, 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?
For treatment of 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092873: 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/K092873
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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