510(k) · Cleared
Recalled · Class II · 2026MSS - Monobloc stem
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 Feb 3, 2026 as substantially equivalent to K170452 (Medacta International S.A., 2017) and 8 other predicates after a 336-day review. Its family tree reaches back 17 generations to 1991. 1 of the 219 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 3, 2026
- Review
- 336 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 1
- Predicates
- 9
Its longest line of descent runs back 17 generations to K911686 (1991). 217 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 219 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations between
- 3 generations backK163669 Humeris ShoulderFx Solutions · 2017
- 2 generations backK213117 FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. · 2022
- 1 generation backK223801 FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc. · 2023
- This deviceK250644 MSS - Monobloc stemMedacta International S.A. · 2026
- Descendant · cites it directly · 0 of its ownK261016 MSS - Humeral reverse liners extensionMedacta International, SA · 2026
Show all 17 generations
- Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 16 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 15 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 14 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 13 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 12 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 10 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 9 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 8 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 7 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 6 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 5 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 4 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 3 generations backK163669 Humeris ShoulderFx Solutions · 2017
- 2 generations backK213117 FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. · 2022
- 1 generation backK223801 FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc. · 2023
- This deviceK250644 MSS - Monobloc stemMedacta International S.A. · 2026
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 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 |
|---|---|---|---|---|---|
| −17 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −16 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −15 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −13 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −12 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −10 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −9 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −8 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −7 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −6 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −5 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −4 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −3 | K163669 | Humeris Shoulder | Fx Solutions | 2017 | — |
| −2 | K213117 | FX V135 Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2022 | — |
| −1 | K223801 | FX V135(TM) Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2023 | — |
| 0 (this device) | K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026 | — |
| +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 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 8 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 13 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 8 | 0 |
| 2005 | 10 | 0 |
| 2006 | 14 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 9 | 0 |
| 2012 | 9 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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? (9)
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 7…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: FX V135™ Shoulder Prosthesis, K223801, FX Shoulder US… | 2017 |
| * | K223801 | FX V135(TM) Shoulder ProsthesisSummary page 7…ary Predicate device: Medacta Shoulder System, K170452, Medacta International SA Additional Predicate devices: FX V135™ Shoulder Prosthesis, K223801, FX Shoulder USA, Inc FX V135™ Shoulder Prosthesis, K213117, FX Shoulder USA, Inc Medacta Anatomic Should… | 2023 |
| * | K213117 | FX V135 Shoulder ProsthesisSummary page 7…International SA Additional Predicate devices: FX V135™ Shoulder Prosthesis, K223801, FX Shoulder USA, Inc FX V135™ Shoulder Prosthesis, K213117, FX Shoulder USA, Inc Medacta Anatomic Shoulder Prosthesis, K170910, Medacta International SA Medacta Sho… | 2022 |
| * | K170910 | Medacta Anatomic Shoulder ProsthesisSummary page 7…ulder Prosthesis, K223801, FX Shoulder USA, Inc FX V135™ Shoulder Prosthesis, K213117, FX Shoulder USA, Inc Medacta Anatomic Shoulder Prosthesis, K170910, Medacta International SA Medacta Shoulder System Short Humeral Diaphysis, K180089, Medacta International SA… | 2017 |
| * | K180089 | Medacta Shoulder System Short Humeral DiaphysisSummary page 7…17, FX Shoulder USA, Inc Medacta Anatomic Shoulder Prosthesis, K170910, Medacta International SA Medacta Shoulder System Short Humeral Diaphysis, K180089, Medacta International SA Glenoid Reconstruction System – Full Wedge Baseplate, K231911, Medacta International… | 2018 |
| * | K231911 | Glenoid Reconstruction System – Full Wedge BaseplateSummary page 7…ional SA Medacta Shoulder System Short Humeral Diaphysis, K180089, Medacta International SA Glenoid Reconstruction System – Full Wedge Baseplate, K231911, Medacta International SA Humeral Eccentric Reverse Metaphysis, K210207, Medacta International SA… | 2023 |
| * | K210207 | Humeral Eccentric Reverse MetaphysisSummary page 7…al SA Glenoid Reconstruction System – Full Wedge Baseplate, K231911, Medacta International SA Humeral Eccentric Reverse Metaphysis, K210207, Medacta International SA INHANCE Reverse Shoulder System, K212737, Depuy Ireland UC HUMELOCK II Cementle… | 2021 |
| * | K212737 | INHANCE™ Reverse Shoulder SystemSummary page 7…, Medacta International SA Humeral Eccentric Reverse Metaphysis, K210207, Medacta International SA INHANCE Reverse Shoulder System, K212737, Depuy Ireland UC HUMELOCK II Cementless shoulder system, K130759, Fx Solutions MSS – Monobloc stem… | 2022 |
| * | K130759 | Humelock II Cementless Shoulder SystemSummary page 7…Metaphysis, K210207, Medacta International SA INHANCE Reverse Shoulder System, K212737, Depuy Ireland UC HUMELOCK II Cementless shoulder system, K130759, Fx Solutions MSS – Monobloc stem Medacta International SA T… | 2013 |
| † | K202022 | GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS… | 2020 |
| † | K202568 | Mpact® 3D Metal Implants - DMLS Technology | 2021 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2026 | Class II | Z-2618-2026 | Device Design | Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than… |
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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 61 of the 217 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. 2026, 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?
Reverse Shoulder Prosthesis 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…
Read the full statement (873 words)
Reverse Shoulder Prosthesis
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.
Anatomic Shoulder Prosthesis
The Medacta Anatomic Shoulder Prosthesis is intended for use as a hemi or total shoulder replacement for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application.
The humeral stems are intended for cemented or cementless use.
The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and 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 for the device to offer full function in vivo.
The glenoid component is intended for cemented application.
The humeral short stem is intended for cementless use.
Reverse Shoulder Prosthesis – monobloc stem
The reverse shoulder prosthesis using the standard monobloc stem 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 standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.
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 using the short monobloc stem 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 short monobloc stem is intended for cementless use only.
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.
Anatomic Shoulder Prosthesis – monobloc stem
The anatomic shoulder prosthesis using the standard monobloc stem is intended for use as a hemi or total shoulder replacement. It is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application.
The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.
The anatomic shoulder prosthesis using the short monobloc stem is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and 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 for the device to offer full function in vivo.
The glenoid component is intended for cemented application.
The short monobloc stem is intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250644: MSS - Monobloc stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250644
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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