510(k) · Cleared
ClearedShoulder System - TiNbN Coating
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 Mar 2, 2021 as substantially equivalent to K193175 (Medacta Inernational SA, 2020) and 4 other predicates after a 69-day review. Its family tree reaches back 16 generations to 1991. 1 of the 234 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 2, 2021
- Review
- 69 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K911686 (1991). 234 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 234 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 backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK140082 Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014
- 1 generation backK180089 Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A. · 2018
- This deviceK203755 Shoulder System - TiNbN CoatingMedacta International S.A. · 2021
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 backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 9 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 8 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 7 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 6 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 5 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 4 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK140082 Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014
- 1 generation backK180089 Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A. · 2018
- This deviceK203755 Shoulder System - TiNbN CoatingMedacta International S.A. · 2021
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder5 generations back · 2008
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 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −9 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −8 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −7 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −6 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −5 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −4 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −3 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −2 | K140082 | Aequalis (TM) Ascent (TM) Flex Shoulder System | Tornier S.A.S. | 2014 | — |
| −1 | K180089 | Medacta Shoulder System Short Humeral Diaphysis | Medacta International S.A. | 2018 | — |
| 0 (this device) | 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 |
| 1981 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 7 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 12 | 0 |
| 1995 | 11 | 0 |
| 1996 | 17 | 0 |
| 1997 | 8 | 0 |
| 1998 | 10 | 0 |
| 1999 | 9 | 0 |
| 2000 | 15 | 0 |
| 2001 | 15 | 0 |
| 2002 | 11 | 0 |
| 2003 | 12 | 0 |
| 2004 | 6 | 0 |
| 2005 | 8 | 0 |
| 2006 | 11 | 0 |
| 2007 | 10 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 8 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K193175 | Lateralized GlenosphereSummary page 5…te Device Substantial equivalence is claimed to the following devices: Primary predicate device: Lateralized Glenosphere (Medacta Shoulder Reverse System), K193175, Medacta International Additional predicate device: Glenosphere (Medacta Shoulder Reverse System), K17045… | 2020 |
| * | K170452 | Medacta Shoulder SystemSummary page 5…ere (Medacta Shoulder Reverse System), K193175, Medacta International Additional predicate device: Glenosphere (Medacta Shoulder Reverse System), K170452, Medacta International Humeral Head (Medacta Shoulder Anatomical System), K170910, Medacta International GM… | 2017 |
| * | K170910 | Medacta Anatomic Shoulder ProsthesisSummary page 5…predicate device: Glenosphere (Medacta Shoulder Reverse System), K170452, Medacta International Humeral Head (Medacta Shoulder Anatomical System), K170910, Medacta International GMK Total Knee System (TiNbN) Coating, K202684, Medacta International… | 2017 |
| * | K202684 | GMK Total Knee System - TiNbN CoatingSummary page 5…452, Medacta International Humeral Head (Medacta Shoulder Anatomical System), K170910, Medacta International GMK Total Knee System (TiNbN) Coating, K202684, Medacta International K203… | 2020 |
| * | K180089 | Medacta Shoulder System Short Humeral DiaphysisSummary page 6…6 === K203755 p. 2/5 Medacta Shoulder System Short Humeral Diaphysis, K180089, Medacta International IV. Device Description The Shoulder System - TiNbN Coating is a line extension to the Shoulder Sys… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 80 of the 233 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Medacta Anatomic Shoulder Prosthesis 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…
Read the full statement (334 words)
The Medacta Anatomic Shoulder Prosthesis 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 humeral stems are intended for cemented or cementless use.
The Medacta Anatomic Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, 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.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203755 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203755: Shoulder System - TiNbN Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203755
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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