510(k) · Cleared
ClearedSorbie Total Elbow System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Cleared on Feb 5, 1996 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Feb 5, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- JDB
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK955099 Sorbie Total Elbow SystemWrightmedicaltechnologyinc · 1996
- Descendant · cites it directly · 7 of its ownK050848 Tornier Elbow ProsthesisTornier · 2005
- Descendant · cites it directly · 7 of its ownK031218 Modification to Tornier Total Elbow ProsthesisTornier · 2003
- Descendant · 2 generations on · 6 of its ownK070787 Latitude Elbow ProthesisTornier · 2007
- Descendant · 2 generations on · 5 of its ownK100562 Latitude Elbow ProsthesisTornier, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 4 of its ownK171010 Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K050848Tornier Elbow ProsthesisTornier · 2005 · cites it directly7descendants
- K031218Modification to Tornier Total Elbow ProsthesisTornier · 2003 · cites it directly7descendants
- K070787Latitude Elbow ProthesisTornier · 2007 · 2 generations on6descendants
- K100562Latitude Elbow ProsthesisTornier, Inc. · 2010 · 2 generations on5descendants
- K171010Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955099 | Sorbie Total Elbow System | Wrightmedicaltechnologyinc | 1996 | — |
| +1 | K050848 | Tornier Elbow Prosthesis | Tornier | 2005 | — |
| +1 | K031218 | Modification to Tornier Total Elbow Prosthesis | Tornier | 2003 | — |
| +2 | K070787 | Latitude Elbow Prothesis | Tornier | 2007 | — |
| +2 | K100562 | Latitude Elbow Prosthesis | Tornier, Inc. | 2010 | 2 |
| +3 | K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDB? 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 JDB device
- #1 K222807 TEMA Elbow system - Line extensionscore 4.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K050848 (Tornier, 2005) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JDB devicesJDB Prosthesis, Elbow, Semi-Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JDB
Too few JDB 510(k)s in any year since 2007 to give a median.
Recalls per year · JDB
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDB
38in 2025
MAUDE reports naming product code JDB, 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 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 44 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 1 | — | 0 | 26 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 0 | — | 0 | 31 |
| 2020 | 1 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 1 | — | 0 | 58 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 1 | 163 |
| 2025 | 0 | — | 0 | 38 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K955099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955099: Sorbie Total Elbow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955099
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026