510(k) · Cleared
ClearedLaki Hand Fixation System, Model TFX.3X.06.X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sintea Biotech, Inc. · JEC Component, Traction, Invasive
Cleared on Apr 7, 2009 as substantially equivalent to K880282 (Lima-Lto, Inc., 1988) after a 204-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Apr 7, 2009
- Review
- 204 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880282 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK880282 Lima-Lto. Sem Modular External StablizerLima-Lto, Inc. · 1988
- This deviceK082679 Laki Hand Fixation System, Model TFX.3X.06.XSintea Biotech, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880282 | Lima-Lto. Sem Modular External Stablizer | Lima-Lto, Inc. | 1988 | — |
| 0 (this device) | K082679 | Laki Hand Fixation System, Model TFX.3X.06.X | Sintea Biotech, Inc. | 2009 | — |
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 JEC? 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 JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K880282 | Lima-Lto. Sem Modular External StablizerSummary page 1…so that a pulling force (traction) may be applied to the skeletal system. V. Performance Data Please see 5 10(k) submission for the SEM Modular External Stabilizer, K880282. VI. Substantial Equivalence Sintea Biotech, Inc. believes that the LAKI Hand Fixation System is substantially equivalent to the… | 1988 |
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 no recall.
- 1 other device also cites its predicate K880282.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LAKI device is intended to be used for fixation of bone fractures of long bones in fingers. The LAKI device is a semi-invasive device intended to be attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082679 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082679: Laki Hand Fixation System, Model TFX.3X.06.X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082679
Report an extraction error
Are you the manufacturer?
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