510(k) · Cleared
ClearedLateralized Glenosphere
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta Inernational SA · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Aug 11, 2020 as substantially equivalent to K170452 (Medacta International S.A., 2017) and 2 other predicates after a 267-day review. Its family tree reaches back 11 generations to 1991. 1 later device descends from it.
- Decided
- Aug 11, 2020
- Review
- 267 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K911686 (1991). 65 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 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 backK112144 Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder…Tornier · 2012
- 1 generation backK170452 Medacta Shoulder SystemMedacta International S.A. · 2017
- This deviceK193175 Lateralized GlenosphereMedacta Inernational SA · 2020
- Descendant · cites it directly · 0 of its ownK203755 Shoulder System - TiNbN CoatingMedacta International S.A. · 2021
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 backK112144 Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder…Tornier · 2012
- 1 generation backK170452 Medacta Shoulder SystemMedacta International S.A. · 2017
- This deviceK193175 Lateralized GlenosphereMedacta Inernational SA · 2020
Most influential descendants
Showing 1 of 1 · See all- K203755Shoulder System - TiNbN CoatingMedacta International S.A. · 2021 · cites it directly0descendants
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 | K112144 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis… | Tornier | 2012 | — |
| −1 | K170452 | Medacta Shoulder System | Medacta International S.A. | 2017 | — |
| 0 (this device) | K193175 | Lateralized Glenosphere | Medacta Inernational SA | 2020 | — |
| +1 | K203755 | Shoulder System - TiNbN Coating | Medacta International S.A. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K170452 | Medacta Shoulder SystemSummary page 4…II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: Glenosphere (Medacta Shoulder Reverse System), K170452, Medacta International SA; Reference Device: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, K161742, Tor… | 2017 |
| * | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidSummary page 4…enosphere (Medacta Shoulder Reverse System), K170452, Medacta International SA; Reference Device: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, K161742, Tornier, Inc. IV. Device Description The Lateralized Glenosphere are line extensions to the Medacta Shoulder Reverse Syste… | 2016 |
| * | K112144 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Summary page 6…e System) K170452, with the only exception of the grade of lateralization of the COR, feature shared with the other predicate AEQUALISTM REVERSED II Shoulder Prosthesis (K112144). This new option of lateralization allows the surgeon to intraoperatively select the desired level of ROM and resulting joint te… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203755 | Shoulder System - TiNbN Coating | 2021 | 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 29 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 65 ancestors have a recall of any class.
- Of its descendants, K203755 (Medacta International S.A., 2021) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K170452.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193175: Lateralized Glenosphere.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193175
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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