510(k) · Cleared
ClearedLigamentotaxor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arex USA · HTY Pin, Fixation, Smooth
Cleared on Aug 17, 2010 as substantially equivalent to K980370 (Biomet, Inc., 1998) and 1 other predicate after a 229-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Aug 17, 2010
- Review
- 229 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970713 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970713 Compass Universal HingeSmith & Nephew, Inc., Orthopaedic Div. · 1997
- 1 generation backK980370 Biosymmetric Proximal Interphalangeal Joint FixatorBiomet, Inc. · 1998
- This deviceK094043 LigamentotaxorArex USA · 2010
- Descendant · cites it directly · 1 of its ownK132731 Digifix External Fixation SystemVirak Orthopedic Research, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK192465 DigiFix Sterile KitVirak Orthopedics, LLC · 2019
- Descendant · cites it directly · 0 of its ownK122415 X-Fix Dynamic External DistractorArex USA, LLC · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970713 | Compass Universal Hinge | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| −1 | K980370 | Biosymmetric Proximal Interphalangeal Joint Fixator | Biomet, Inc. | 1998 | — |
| 0 (this device) | K094043 | Ligamentotaxor | Arex USA | 2010 | — |
| +1 | K132731 | Digifix External Fixation System | Virak Orthopedic Research, LLC | 2014 | — |
| +2 | K192465 | DigiFix Sterile Kit | Virak Orthopedics, LLC | 2019 | — |
| +1 | K122415 | X-Fix Dynamic External Distractor | Arex USA, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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 |
|---|---|---|---|
| * | K980370 | Biosymmetric Proximal Interphalangeal Joint FixatorSummary page 1…HTY Classification Name: Pin, Fixation, Smooth Classification: Class 1I Predicate Device Name: BioSymetRic external fixator (K980370) marketed by Biomnet Inc and the Compass System (K9707 13) of Smith a… | 1998 |
| * | K970713 | Compass Universal HingeSummary page 1…Class 1I Predicate Device Name: BioSymetRic external fixator (K980370) marketed by Biomnet Inc and the Compass System (K9707 13) of Smith and Nephew Device Description: The Ligamentotaxor is an external fixation syst… | 1997 |
What descends from it? (3)
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132731 (Virak Orthopedic Research, LLC, 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K980370.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Ligamentotaxor is an external fixation system intended for
use in the treatment of complex fracture dislocations, stable and
unstable dislocations, fracture luxations, and pilon fractures in the
PIP joint.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K094043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K094043: Ligamentotaxor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094043
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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