510(k) · Cleared
ClearedUltimax Haig II Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Aug 12, 1999 after a 70-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Aug 12, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK991889 Ultimax Haig II Nail SystemEncore Orthopedics, Inc. · 1999
- 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 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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) | K991889 | Ultimax Haig II Nail System | Encore Orthopedics, Inc. | 1999 | — |
| +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 | 1 | 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 LXT? 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 LXT device
- #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102528 | N-Force Fixation System | 2011 | 5 |
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 LXT devicesLXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LXT
Too few LXT 510(k)s in any year since 2007 to give a median.
Recalls per year · LXT
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXT
7in 2025
MAUDE reports naming product code LXT, 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 | 1 | — | 1 | 26 |
| 2008 | 1 | — | 0 | 58 |
| 2009 | 1 | — | 7 | 41 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 1 | — | 0 | 85 |
| 2012 | 0 | — | 0 | 42 |
| 2013 | 2 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 35 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 66 |
| 2018 | 0 | — | 2 | 73 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The UltiMax Haig II Nail System is indicated for single use to stabilize intracapsular fractures of the neck of the femur; class L, class II, class III, and class IV trochanteric and subtrocanteric fractures with appropriate additional postoperative precautions against weight-bearing and against more than sedentary activity, and arthrodesis 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/K991889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991889: Ultimax Haig II Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991889
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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