510(k) · Cleared
ClearedOVOMotion Reverse Shoulder Arthroplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrosurface, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jun 24, 2021 as substantially equivalent to K183039 (Stryker GmbH, 2019) after a 220-day review. Its family tree reaches back 16 generations to 1991. 1 of the 120 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 24, 2021
- Review
- 220 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K911686 (1991). 119 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 120 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 backK172210 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker Trauma AG · 2017
- 2 generations backK181742 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2018
- 1 generation backK183039 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2019
- This deviceK203375 OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc. · 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 backK130895 Reunion Rsa Shoulder SystemHowmedica Osteonics Corp. · 2013
- 4 generations backK161863 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2016
- 3 generations backK172210 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker Trauma AG · 2017
- 2 generations backK181742 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2018
- 1 generation backK183039 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2019
- This deviceK203375 OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc. · 2021
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder6 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 | K130895 | Reunion Rsa Shoulder System | Howmedica Osteonics Corp. | 2013 | — |
| −4 | K161863 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2016 | — |
| −3 | K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker Trauma AG | 2017 | — |
| −2 | K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2018 | — |
| −1 | K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2019 | — |
| 0 (this device) | K203375 | OVOMotion Reverse Shoulder Arthroplasty System | Arthrosurface, Inc. | 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 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 11 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (1)
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 |
|---|---|---|---|
| * | K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Summary page 4…ss: II Product Code: PHX Predicate Devices Primary Predicate - Stryker Orthopedics ReUnion Reverse Shoulder Arthroplasty System (RSA) (K183039). Reference Devices- Arthrosurface’s OVOMotion Shoulder Arthroplasty System (K173964) Arthrosurface WristMoti… | 2019 |
| † | K173964 | OVOMotion Shoulder Arthroplasty System | 2018 |
| † | K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | 2020 |
| † | K052086 | Encore Reverse Shoulder Prosthesis Humeral Stem Adapter | 2005 |
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 · 6 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 10 companies; a new generation was cleared every 12 months on median.
- 37 of the 119 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K183039.
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 OVOMotion Reverse Shoulder Arthroplasty System is intended for primary total shoulder replacement in a reverse shoulder configuration. The device is indicated for a patient with painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis. The humeral head and neck and glenoid vault should be of sufficient bone stock to support loading. The patient’s joint must have gross rotator cuff deficiency, a…
Read the full statement (107 words)
The OVOMotion Reverse Shoulder Arthroplasty System is intended for primary total shoulder replacement in a reverse shoulder configuration. The device is indicated for a patient with painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis. The humeral head and neck and glenoid vault should be of sufficient bone stock to support loading. The patient’s joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implants.
Glenoid Baseplate components are intended for cementless use with the addition of screw fixation. The Humeral Stem components are intended for both cemented and cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203375: OVOMotion Reverse Shoulder Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203375
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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