510(k) · Cleared
ClearedTrimed X-Fix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TriMed, Inc. · NDK System, External Fixator (With Metallic Invasive Components)
Cleared on Sep 15, 2010 as substantially equivalent to K974911 (Avanta Orthopaedics, Inc., 1998) and 1 other predicate after a 121-day review. Its family tree reaches back 3 generations to 1983. 1 later device descends from it.
- Decided
- Sep 15, 2010
- Review
- 121 days
- Class
- Class II
- Product code
- NDK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K831576 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 2 generations backK974911 External FixatorAvanta Orthopaedics, Inc. · 1998
- 1 generation backK981716 External FixationAvanta Orthopaedics, Inc. · 1998
- This deviceK101375 Trimed X-FixTriMed, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK122208 External Fixator SystemChristopher D. Endara · 2012
Most influential descendants
Showing 1 of 1 · See all- K122208External Fixator SystemChristopher D. Endara · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −2 | K974911 | External Fixator | Avanta Orthopaedics, Inc. | 1998 | — |
| −1 | K981716 | External Fixation | Avanta Orthopaedics, Inc. | 1998 | — |
| 0 (this device) | K101375 | Trimed X-Fix | TriMed, Inc. | 2010 | — |
| +1 | K122208 | External Fixator System | Christopher D. Endara | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 NDK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K974911 | External Fixator | 1998 |
| * | K981716 | External FixationSummary page 1…grade stainless steel. III. Substantial Equivalence: The TriMed X-Fix System has been compared to the Avanta Orthopaedics External Fixator (K97491 l/K981716). The X-Fix is equivalent in dimensions, design and materials. X-Fix System Traditional 516(K)… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122208 | External Fixator System | 2012 | 0 |
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 27 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K122208 (Christopher D. Endara, 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K974911.
How does its category compare?
All NDK devicesNDK System, External Fixator (With Metallic Invasive Components): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NDK
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NDK
Too few NDK 510(k)s in any year since 2007 to give a median.
Recalls per year · NDK
No recall names NDK since 2007.
Adverse event reports per year · NDK
1in 2023
MAUDE reports naming product code NDK, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TriMed X-Fix is a unilateral external fixation device. It is intended to be used in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101375: Trimed X-Fix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101375
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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