510(k) · Cleared
ClearedSeviin Surface Replacement Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ingen Orthopedics, LLC · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Aug 26, 2013 as substantially equivalent to K010657 (Biomet Manufacturing, Inc., 2001) and 1 other predicate after a 168-day review. Its family tree reaches back 7 generations to 1980.
- Decided
- Aug 26, 2013
- Review
- 168 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K800494 (1980). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 6 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 5 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 4 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
- 3 generations backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
- 2 generations backK033516 Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc. · 2003
- 1 generation backK062661 Aequalis Resurfacing HeadTornier · 2006
- This deviceK130635 Seviin Surface Replacement ShoulderIngen Orthopedics, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −6 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −5 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −4 | K010827 | Copeland MB/HA Resurfacing Humeral Heads | Biomet Orthopedics, Inc. | 2001 | 1 |
| −3 | K031971 | Global Cap Resurfacing Replacement Shoulder | DePuy Orthopaedics, Inc. | 2003 | — |
| −2 | K033516 | Depuy Global Cap HA Resurfacing Shoulder Humeral Heads | DePuy Orthopaedics, Inc. | 2003 | — |
| −1 | K062661 | Aequalis Resurfacing Head | Tornier | 2006 | — |
| 0 (this device) | K130635 | Seviin Surface Replacement Shoulder | Ingen Orthopedics, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (2)
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 |
|---|---|---|---|
| * | K010657 | Copeland MB Resurfacing Humeral HeadsSummary page 1…d cemented prosthesis; Class 11 Product Codes: FISD, KWVS, KWTr Substantially Equivalent Devices: Copeland MB Resurfacing Humeral Heads, K010657, cleared Sept 14, 2001 Tornier Aequalis Resurfacing H-ead, 1(0… | 2001 |
| * | K062661 | Aequalis Resurfacing HeadSummary page 1…and MB Resurfacing Humeral Heads, K010657, cleared Sept 14, 2001 Tornier Aequalis Resurfacing H-ead, 1(062661, cleared December 22, 2006 Device Description: The SEVIIN Surface Replacement Shoulder… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 24 ancestors have a recall of any class.
- 4 other devices also cite its predicate K010657.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff. Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis) * Correction of…
Read the full statement (98 words)
The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff.
Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by:
* Rheumatoid arthritis
* Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis)
* Correction of functional deformity
* Humeral head fractures
* Traumatic arthritis
The SEVIIN Resurfacing Humeral Heads are intended for cemented and uncemented applications. The glenoid components, when used, are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130635: Seviin Surface Replacement Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130635
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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