510(k) · Cleared
ClearedXT3 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biodynamik, Inc. · JDW Pin, Fixation, Threaded
Cleared on Jan 22, 2025 as substantially equivalent to K955848 (Orthofix, Inc., 1996) and 1 other predicate after a 253-day review. Its family tree reaches back 4 generations to 1980. 1 later device descends from it.
- Decided
- Jan 22, 2025
- Review
- 253 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K802814 (1980). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK802814 Orthofix Axialexternal Fixation Sys.Cintor Orthopaedic Div. · 1980
- 3 generations backK970751 Heidelberg External FixatorSmith & Nephew, Inc., Orthopaedic Div. · 1997
- 2 generations backK090926 Smith & Nephew Rail SystemSmith & Nephew, Inc. · 2009
- 1 generation backK200518 Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd. · 2020
- This deviceK241357 XT3 SystemBiodynamik, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK260073 XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K802814 | Orthofix Axialexternal Fixation Sys. | Cintor Orthopaedic Div. | 1980 | — |
| −3 | K970751 | Heidelberg External Fixator | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| −2 | K090926 | Smith & Nephew Rail System | Smith & Nephew, Inc. | 2009 | — |
| −1 | K200518 | Pitkar External Fixation System - Rail Mechanism | S.H.Pitkar Orthotools Pvt., Ltd. | 2020 | — |
| 0 (this device) | K241357 | XT3 System | Biodynamik, Inc. | 2025 | — |
| +1 | K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 JDW? 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 JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 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 5…3040 Product Code(s) JDW, KTT | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K955848 Orthofix Modulsystem JDW K200518 Pitkar External Fixation System - Rail Mechanism KTT Device Description Summary 21 CFR 807.92(a)… | 1996 |
| * | K200518 | Pitkar External Fixation System - Rail MechanismSummary page 5…Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K955848 Orthofix Modulsystem JDW K200518 Pitkar External Fixation System - Rail Mechanism KTT Device Description Summary 21 CFR 807.92(a)(4) The XT3 System is composed o… | 2020 |
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 |
|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | 2026 | 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 45 years and passes through 5 companies; a new generation was cleared every 12.1 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K260073 (Biodynamik, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K955848.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, 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 | 2 | — | 0 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BioDynamik XT3 System is indicated for fracture fixation and bone transport of the tibia in adults.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241357: XT3 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241357
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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