510(k) · Cleared
ClearedAlta Dome and Plunger (Mec Hip Bolt)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jun 13, 1996 after a 77-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Jun 13, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK961213 Alta Dome and Plunger (Mec Hip Bolt)Howmedica Corp. · 1996
- Descendant · cites it directly · 5 of its ownK102528 N-Force Fixation SystemInnovision, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK132244 N-Force Fixation SystemInnovision, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK151146 N-Force Fixation SystemInnovision, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK142776 Flow-ScrewFlow-Fx, LLC · 2015
- Descendant · 3 generations on · 0 of its ownK173556 Injection ScrewBiedermann Medtech, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K102528N-Force Fixation SystemInnovision, Inc. · 2011 · cites it directly5descendants
- K132244N-Force Fixation SystemInnovision, Inc. · 2014 · 2 generations on3descendants
- K151146N-Force Fixation SystemInnovision, Inc. · 2015 · 2 generations on1descendant
- K142776Flow-ScrewFlow-Fx, LLC · 2015 · 2 generations on1descendant
- K173556Injection ScrewBiedermann Medtech, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961213 | Alta Dome and Plunger (Mec Hip Bolt) | Howmedica Corp. | 1996 | — |
| +1 | K102528 | N-Force Fixation System | Innovision, Inc. | 2011 | — |
| +2 | K132244 | N-Force Fixation System | Innovision, Inc. | 2014 | — |
| +2 | K151146 | N-Force Fixation System | Innovision, Inc. | 2015 | — |
| +2 | K142776 | Flow-Screw | Flow-Fx, LLC | 2015 | — |
| +3 | K173556 | Injection Screw | Biedermann Medtech, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 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 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 21.4 · 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? (3)
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 |
|---|---|---|---|
| * | — | Alta® Dome and Plunger Named without a submission number | |
| * | — | Howmedica Haig Nail Named without a submission number | |
| * | — | Zimmer Haig Nail Named without a submission number |
What descends from it? (7)
2 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, K102528 (Innovision, Inc., 2011) has gone furthest, with 5 descendants of its own.
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 | — |
What is it indicated for?
The Alta® Dome and Plunger, previously cleared by the FDA, is a titanium alloy device for the fixation of intracapsular and extracapsular (intertrochanteric) fractures of the hip.
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/K961213 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961213: Alta Dome and Plunger (Mec Hip Bolt).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961213
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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