510(k) · Cleared
ClearedTrueLok Evo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 5, 2021 as substantially equivalent to K941048 (Applied Osteo Systems, Inc., 1994) after a 128-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Nov 5, 2021
- Review
- 128 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941048 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941048 True/Lok Monolateral/Bilateral FixatorApplied Osteo Systems, Inc. · 1994 · Recalled
- This deviceK212044 TrueLok EvoOrthofix Srl · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941048 | True/Lok Monolateral/Bilateral Fixator | Applied Osteo Systems, Inc. | 1994 | 1 |
| 0 (this device) | K212044 | TrueLok Evo | Orthofix Srl | 2021 | — |
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? (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 |
|---|---|---|---|
| * | K941048 | True/Lok Monolateral/Bilateral FixatorSummary page 4…imary Predicate Devices 510(k) Manufacturer Number TRUE LOK MONOLATERAL/BILATERAL K941048 Orthofix S.r.l. FIXATOR Reference Device Orthofix TL-HEX True Lok Hexapod System K152171 Orthof… | 1994 |
| † | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | 2015 |
| † | K944092 | Additional Accessories for the Orthofix System | 1995 |
| † | K955848 | Orthofix Modulsystem | 1996 |
| † | K974186 | Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating | 1998 |
| † | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K941048.
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. 2021, this device’s year, is highlighted.
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 TrueLok™ EVO is intended to provide bone fixation.
The TrueLok™ EVO is indicated for fractures, pseudarthrosis / non-unions, lengthening, joint arthrodesis and correction of bony or soft tissue deformities and defects (e.g. bone transport) in long bones and in the foot.
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/K212044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212044: TrueLok Evo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212044
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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