510(k) · Cleared
ClearedX-Fix Dynamic External Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arex USA, LLC · HTY Pin, Fixation, Smooth
Cleared on Mar 15, 2013 as substantially equivalent to K094043 (Arex USA, 2010) after a 219-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 15, 2013
- Review
- 219 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970713 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK970713 Compass Universal HingeSmith & Nephew, Inc., Orthopaedic Div. · 1997
- 2 generations backK980370 Biosymmetric Proximal Interphalangeal Joint FixatorBiomet, Inc. · 1998
- 1 generation backK094043 LigamentotaxorArex USA · 2010
- This deviceK122415 X-Fix Dynamic External DistractorArex USA, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970713 | Compass Universal Hinge | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| −2 | K980370 | Biosymmetric Proximal Interphalangeal Joint Fixator | Biomet, Inc. | 1998 | — |
| −1 | K094043 | Ligamentotaxor | Arex USA | 2010 | — |
| 0 (this device) | K122415 | X-Fix Dynamic External Distractor | Arex USA, LLC | 2013 | — |
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? (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 |
|---|---|---|---|
| * | K094043 | LigamentotaxorSummary page 1…0 Product Code: HTY Classification Name: Pin, Fixation, Smooth Classification: Class II Predicate Device Name: AREX USA Ligamentotaxor (K094043) Device Description: The AREX USA X-FIX is a single use, lightweight, low profile external fixatio… | 2010 |
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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K094043.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 X-FIX 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/K122415 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122415: X-Fix Dynamic External Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122415
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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