510(k) · Cleared
ClearedMSS - Humeral reverse liners extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Oct 31, 2025 as substantially equivalent to K170452 (Medacta International S.A., 2017) and 2 other predicates after a 267-day review. Its family tree reaches back 16 generations to 1991. 1 of the 85 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 31, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K911686 (1991). 83 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 85 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations between
- 3 generations backK173900 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018
- 2 generations backK193372 Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc. · 2020
- 1 generation backK231911 Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A. · 2023
- This deviceK250338 MSS - Humeral reverse liners extensionMedacta International S.A. · 2025
- Descendant · cites it directly · 0 of its ownK261016 MSS - Humeral reverse liners extensionMedacta International, SA · 2026
Show all 16 generations
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 15 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 14 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 13 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 12 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 9 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 8 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 7 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 6 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 5 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- 4 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- 3 generations backK173900 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018
- 2 generations backK193372 Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc. · 2020
- 1 generation backK231911 Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A. · 2023
- This deviceK250338 MSS - Humeral reverse liners extensionMedacta International S.A. · 2025
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder4 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K261016MSS - Humeral reverse liners extensionMedacta International, SA · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −15 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −12 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −9 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −8 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −7 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −6 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| −5 | K130129 | Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2013 | — |
| −4 | K142863 | Univers Rivers Shoulder Prosthesis System | Arthrex, Inc. | 2014 | — |
| −3 | K173900 | Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. | 2018 | — |
| −2 | K193372 | Univers Revers Modular Glenoid System (Augemented baseplates) | Arthrex, Inc. | 2020 | — |
| −1 | K231911 | Glenoid Reconstruction System – Full Wedge Baseplate | Medacta International S.A. | 2023 | — |
| 0 (this device) | K250338 | MSS - Humeral reverse liners extension | Medacta International S.A. | 2025 | — |
| +1 | K261016 | MSS - Humeral reverse liners extension | Medacta International, SA | 2026 | — |
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 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 1 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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 5…II III. Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: Medacta Shoulder System, K170452, Medacta International SA Additional Predicate devices Glenoid Reconstruction System – Full Wedge Baseplate,… | 2017 |
| * | K231911 | Glenoid Reconstruction System – Full Wedge BaseplateSummary page 5… Medacta Shoulder System, K170452, Medacta International SA Additional Predicate devices Glenoid Reconstruction System – Full Wedge Baseplate, K231911, Medacta International SA DELTA XTEND Reverse Shoulder System, K062250, DePuy Orthopaedics, Inc.… | 2023 |
| * | K062250 | Delta Xtend Reverse Shoulder SystemSummary page 5…evices Glenoid Reconstruction System – Full Wedge Baseplate, K231911, Medacta International SA DELTA XTEND Reverse Shoulder System, K062250, DePuy Orthopaedics, Inc. Reference device: GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing P… | 2007 |
| † | K202022 | GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS… | 2020 |
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 |
|---|---|---|---|
| K261016 | MSS - Humeral reverse liners extension | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 22 of the 83 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K261016 (Medacta International, SA, 2026) 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. 2025, 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 deficient rotator cuff shoulder joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is…
Read the full statement (236 words)
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 deficient rotator cuff
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 stems are intended for cemented or cementless use.
The Glenoid Reconstruction System baseplate is intended for cementless application with the
addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can
be used to provide additional fixation.
The Reverse Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder
replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. 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 short stem is intended
for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless
application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction
System central screw can be used to provide additional fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250338: MSS - Humeral reverse liners extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250338
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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