510(k) · Cleared
ClearedOmega 3 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Aug 15, 2006 after a 25-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Aug 15, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK062066 Omega 3 SystemHowmedica Osteonics Corp. · 2006
- Descendant · cites it directly · 2 of its ownK172872 DePuy Synthes Femoral Neck SystemDePuy Synthes · 2018
- Descendant · cites it directly · 1 of its ownK182154 Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC · 2018
- Descendant · cites it directly · 1 of its ownK181640 X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics · 2018
- Descendant · cites it directly · 0 of its ownK230764 OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023
- Descendant · 2 generations on · 0 of its ownK221621 Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics · 2023
Most influential descendants
Showing 5 of 5 · See all- K172872DePuy Synthes Femoral Neck SystemDePuy Synthes · 2018 · cites it directly2descendants
- K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC · 2018 · cites it directly1descendant
- K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics · 2018 · cites it directly1descendant
- K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023 · cites it directly0descendants
- K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062066 | Omega 3 System | Howmedica Osteonics Corp. | 2006 | — |
| +1 | K172872 | DePuy Synthes Femoral Neck System | DePuy Synthes | 2018 | — |
| +1 | K182154 | Depuy Synthes Femoral Neck System | Synthes (USA) Products, LLC | 2018 | — |
| +1 | K181640 | X-BOLT Hip Fracture Fixation System | X-Bolt Orthopaedics | 2018 | — |
| +1 | K230764 | OsteoCentric Integrated Hip Fastener System | OsteoCentric Technologies | 2023 | — |
| +2 | K221621 | Pro-X1™ Trochanteric Nailing System | X-Bolt Orthopedics | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2023 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | — | Omega Plus System Named without a submission number | |
| * | — | Omega 2 System Named without a submission number |
What descends from it? (5)
4 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, K172872 (DePuy Synthes, 2018) has gone furthest, with 2 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 Omega TM Plus, Omega TM 2, and Omega TM 3 Systems are intended for use in the temporary stabilization of types of fractures of the proximal and distal femur. The subject devices are indicated for fixation of proximal and distal femoral fractures including but not limited to:
* Intracapsular and basal neck fractures including transcervical and subcapital fractures
* Intertrochanteric fractures
* Subtrochanteric fractures
* Supracondylar fractures
* Intracondylar fractures
* Osteotomies for patients with diseases or deformities of the hip
* Hip arthrodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062066 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062066: Omega 3 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062066
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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