510(k) · Cleared
ClearedSeviin Reverse Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ingen Orthopedics, LLC · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jul 9, 2012 as substantially equivalent to K053274 (Zimmer GmbH, 2006) and 3 other predicates after a 154-day review. Its family tree reaches back 7 generations to 1991. 1 later device descends from it.
- Decided
- Jul 9, 2012
- Review
- 154 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K911686 (1991). 20 ancestors in all, the oldest K800494 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 4 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 3 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 2 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 1 generation backK053274 Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · Recalled
- This deviceK120374 Seviin Reverse ShoulderIngen Orthopedics, LLC · 2012
- Descendant · cites it directly · 0 of its ownK131277 Seviin Fracture ShoulderIngen Orthopedics, LLC · 2013
Most influential descendants
Showing 1 of 1 · See all- K131277Seviin Fracture ShoulderIngen Orthopedics, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −6 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −3 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −2 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −1 | K053274 | Anatomical Shoulder Inverse/Reverse | Zimmer GmbH | 2006 | 3 |
| 0 (this device) | K120374 | Seviin Reverse Shoulder | Ingen Orthopedics, LLC | 2012 | — |
| +1 | K131277 | Seviin Fracture Shoulder | Ingen Orthopedics, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (4)
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 |
|---|---|---|---|
| * | K053274 | Anatomical Shoulder Inverse/ReverseSummary page 4…21 CFR 888.3660: Shoulder joint metal/polymer semi- constrained cemented prosthesis; Class 11 KWS Zimmer Anatomical Shoulder Inverse/Reverse Total Shoulder Prosthesis, K053274, cleared January 25, 2006 Tornier Aequalis Reversed Shoulder Prosthesis, K041873, cleared August 25, 2004 Encore Medical Encore… | 2006 |
| * | K041873 | Aequalis Reversed Shoulder ProsthesisSummary page 4…s; Class 11 KWS Zimmer Anatomical Shoulder Inverse/Reverse Total Shoulder Prosthesis, K053274, cleared January 25, 2006 Tornier Aequalis Reversed Shoulder Prosthesis, K041873, cleared August 25, 2004 Encore Medical Encore Reverse Shoulder Prosthesis, K041066, cleared March 24, 2005 Genesis Medical Gen… | 2004 |
| * | K041066 | Encore Reverse Shoulder ProsthesisSummary page 4…s, K053274, cleared January 25, 2006 Tornier Aequalis Reversed Shoulder Prosthesis, K041873, cleared August 25, 2004 Encore Medical Encore Reverse Shoulder Prosthesis, K041066, cleared March 24, 2005 Genesis Medical Genesis Total Shoulder Replacement, K043346, cleared January 31, 2005 The SEVIIN Revers… | 2005 |
| * | K043346 | Genesis Total Shoulder Replacement, Model 100-01-00Summary page 4…K041873, cleared August 25, 2004 Encore Medical Encore Reverse Shoulder Prosthesis, K041066, cleared March 24, 2005 Genesis Medical Genesis Total Shoulder Replacement, K043346, cleared January 31, 2005 The SEVIIN Reverse Shoulder is a total shoulder prosthesis designed for use in patients with non-func… | 2005 |
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 |
|---|---|---|---|
| K131277 | Seviin Fracture Shoulder | 2013 | 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 21 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K131277 (Ingen Orthopedics, LLC, 2013) has gone furthest, with 0 descendants of its own.
- 12 other devices also cite its predicate K053274.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 SEVIIN Reverse Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral component is intended for cemented use and the TPS ‘coated metaglene component is intended for cementless use with the addition of screws for fixation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K120374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120374: Seviin Reverse Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120374
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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