510(k) · Cleared
Recalled · Class II · 2024TEMA Elbow system - Line extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Cleared on Oct 26, 2022 as substantially equivalent to K181362 (Lima Corporate S.P.A., 2019) after a 40-day review. Its family tree reaches back 7 generations to 1989. It has been recalled once.
- Decided
- Oct 26, 2022
- Review
- 40 days
- Class
- Class II
- Product code
- JDB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K883665 (1989). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK883665 Coonrad Iii Total ElbowZimmer, Inc. · 1989
- 6 generations backK973357 Coonrad/Morrey Total Elbow, New Hinge PinZimmer, Inc. · 1998 · Recalled
- 5 generations backK031218 Modification to Tornier Total Elbow ProsthesisTornier · 2003
- 4 generations backK070787 Latitude Elbow ProthesisTornier · 2007
- 3 generations backK100562 Latitude Elbow ProsthesisTornier, Inc. · 2010 · Recalled
- 2 generations backK171010 Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017
- 1 generation backK181362 TEMA Elbow SystemLima Corporate S.P.A. · 2019 · Recalled
- This deviceK222807 TEMA Elbow system - Line extensionLima Corporate S.P.A. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K883665 | Coonrad Iii Total Elbow | Zimmer, Inc. | 1989 | — |
| −6 | K973357 | Coonrad/Morrey Total Elbow, New Hinge Pin | Zimmer, Inc. | 1998 | 1 |
| −5 | K031218 | Modification to Tornier Total Elbow Prosthesis | Tornier | 2003 | — |
| −4 | K070787 | Latitude Elbow Prothesis | Tornier | 2007 | — |
| −3 | K100562 | Latitude Elbow Prosthesis | Tornier, Inc. | 2010 | 2 |
| −2 | K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | 2017 | — |
| −1 | K181362 | TEMA Elbow System | Lima Corporate S.P.A. | 2019 | 1 |
| 0 (this device) | K222807 | TEMA Elbow system - Line extension | Lima Corporate S.P.A. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2005 | 3 | 0 |
| 2009 | 1 | 0 |
| 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 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 K193247 LATITUDE EV™ Total Elbow Arthroplastyscore 1.6 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K181362 | TEMA Elbow SystemSummary page 5…rformed. Predicate Devices: Company Device name Cleared via LIMACORPORATE TEMA Elbow system K181362 Summary of technology comparison: TEMA Elbow system – line extension and TEMA Elbow system (predicate device) have extensive and… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2024 | Class II | Z-0744-2025 | Process control | Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 8 of the 19 ancestors have a recall of any class.
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. 2022, this device’s year, is highlighted.
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 | — |
What is it indicated for?
TEMA Elbow system is intended for use in cemented applications for patients suffering from disability due to: 1. Elbow joint destruction which significantly compromises the activities of daily living 2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia. 3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain 4. Revision where other devices or treatments have failed. 5.…
Read the full statement (134 words)
TEMA Elbow system is intended for use in cemented applications for patients suffering from disability due to:
1. Elbow joint destruction which significantly compromises the activities of daily living
2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain
4. Revision where other devices or treatments have failed.
5. Correction of severe functional deformity.
6. Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
7. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion
The unlinked, semi-constrained version is for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of dislocation or disengagement between ulnar and humeral components, when intraoperative manual testing is performed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222807: TEMA Elbow system - Line extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222807
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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