510(k) · Cleared
ClearedSeviin Fracture Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ingen Orthopedics, LLC · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Aug 28, 2013 as substantially equivalent to K043346 (Genesis Medical LLC, 2005) and 3 other predicates after a 114-day review. Its family tree reaches back 12 generations to 1991. 1 of the 83 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 28, 2013
- Review
- 114 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K911686 (1991). 82 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 83 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations between
- 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 1 generation backK092900 Exactech Equinoxe Platform Fracture Stem and Revision Platform…Exactech, Inc. · 2010 · Recalled
- This deviceK131277 Seviin Fracture ShoulderIngen Orthopedics, LLC · 2013
Show all 12 generations
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 10 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 9 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 8 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 5 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 4 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 1 generation backK092900 Exactech Equinoxe Platform Fracture Stem and Revision Platform…Exactech, Inc. · 2010 · Recalled
- This deviceK131277 Seviin Fracture ShoulderIngen Orthopedics, LLC · 2013
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −11 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −8 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −5 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −4 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −3 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −2 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −1 | K092900 | Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture Stem | Exactech, Inc. | 2010 | 2 |
| 0 (this device) | K131277 | Seviin Fracture Shoulder | Ingen Orthopedics, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2012 | 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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 |
|---|---|---|---|
| * | K043346 | Genesis Total Shoulder Replacement, Model 100-01-00Summary page 1…metallic uncernented prosthesis; Class IT Product Codes: K\XS, HID Substantially Equivalent Devices: Genesis l'otal Shoulder Replacement, K043346, cleared Jan 31, 2005 DePuy Global Fx Hmeral Stem, Glohal Advantage… | 2005 |
| * | K984541 | Global FX Humeral Stem, Global Advantage Humeral HeadSummary page 1…ent, K043346, cleared Jan 31, 2005 DePuy Global Fx Hmeral Stem, Glohal Advantage, 1(984541, cleared Jan 14,1999. Exactech Equinoxe Platforma Fracture Stern, 1K092900, clea… | 1999 |
| * | K092900 | Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemSummary page 1…Hmeral Stem, Glohal Advantage, 1(984541, cleared Jan 14,1999. Exactech Equinoxe Platforma Fracture Stern, 1K092900, cleared Jan 7, 2010. Ingen Seviin Reverse Shoulder, K120374, cleared July 9,… | 2010 |
| * | K120374 | Seviin Reverse ShoulderSummary page 1…Exactech Equinoxe Platforma Fracture Stern, 1K092900, cleared Jan 7, 2010. Ingen Seviin Reverse Shoulder, K120374, cleared July 9, 2012.… | 2012 |
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 23 of the 82 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K043346.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The SEVIIN Fracture Shoulder is intended for cemented use for a severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. It is also intended for fracture dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory. The device can…
Read the full statement (218 words)
The SEVIIN Fracture Shoulder is intended for cemented use for a severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. It is also intended for fracture dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory. The device can be used in other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of failed primary component). Hemi-shoulder replacement is also indicated for un-united humeral head fractures and avascular necrosis of the humeral head.
The SEVIIN Fracture Shoulder is also indicated for fracture total shoulder arthroplasty (due to acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint) 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 SEVIIN Fracture Shoulder humeral stems are intended for cemented applications. The glenoid components are intended for cemented use (total shoulder arthroplasty) and the TPS coated metaglene component is intended for cementless use with the addition of screws for fixation (reverse arthroplasty).
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/K131277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131277: Seviin Fracture Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131277
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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