510(k) · Cleared
Recalled · Class II · 2019Corstren Compression Tube & Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Mar 25, 1983 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 12 times.
- Decided
- Mar 25, 1983
- Review
- 64 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 12
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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?
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 10, 2019 | Class II | Z-0326-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Apr 28, 2017 | Class II | Z-2600-2017 | Under Investigation by firm | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. |
| Apr 28, 2017 | Class II | Z-2594-2017 | Under Investigation by firm | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. |
| Apr 28, 2017 | Class II | Z-2593-2017 | Under Investigation by firm | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. |
| Jan 11, 2016 | Class II | Z-1128-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
| Jul 22, 2014 | Class II | Z-2550-2014 | Package design/selection | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations… |
| Oct 11, 2013 | Class II | Z-1003-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
| Jun 19, 2013 | Class II | Z-2093-2013 | Packaging process control | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. |
| Jun 19, 2013 | Class II | Z-2091-2013 | Packaging process control | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. |
| Jun 19, 2013 | Class II | Z-2092-2013 | Packaging process control | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. |
| Jun 19, 2013 | Class II | Z-2094-2013 | Packaging process control | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. |
| Jun 19, 2013 | Class II | Z-2090-2013 | Packaging process control | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
https://510kreport.com/device/K830196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K830196: Corstren Compression Tube & Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830196
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026