510(k) · Cleared
ClearedR-X-Fix External Fixator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R-X-Fix · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jun 29, 2005 as substantially equivalent to K955848 (Orthofix, Inc., 1996) and 1 other predicate after a 69-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it.
- Decided
- Jun 29, 2005
- Review
- 69 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K831576 (1983). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 1 generation backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- This deviceK051017 R-X-Fix External FixatorR-X-Fix · 2005
- Descendant · cites it directly · 0 of its ownK150640 RX-FIX Mini Rail External FixatorWrightmedicaltechnologyinc · 2015
Most influential descendants
Showing 1 of 1 · See all- K150640RX-FIX Mini Rail External FixatorWrightmedicaltechnologyinc · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −1 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| 0 (this device) | K051017 | R-X-Fix External Fixator | R-X-Fix | 2005 | — |
| +1 | K150640 | RX-FIX Mini Rail External Fixator | Wrightmedicaltechnologyinc | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (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 |
|---|---|---|---|
| * | K955848 | Orthofix ModulsystemSummary page 1…, multiple component Class II per 21 CFR section 888.3030 Product Code KTT Equivalent Device Orthofix Dynamic Axial Fixation system (K955848) Fixano Minifix Fixator (K964094) Device Description The R-X-Fix External Fixator is a stable solution for… | 1996 |
| * | K964094 | MinifixSummary page 1…CFR section 888.3030 Product Code KTT Equivalent Device Orthofix Dynamic Axial Fixation system (K955848) Fixano Minifix Fixator (K964094) Device Description The R-X-Fix External Fixator is a stable solution for fractures and for lengthening of small bones. The R-X-F… | 1996 |
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 |
|---|---|---|---|
| K150640 | RX-FIX Mini Rail External Fixator | 2015 | 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 22 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K150640 (Wrightmedicaltechnologyinc, 2015) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K955848.
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.
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 R-X-Fix external fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051017 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051017: R-X-Fix External Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051017
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