510(k) · Cleared
ClearedXT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
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 Feb 10, 2026 as substantially equivalent to K241357 (Biodynamik, Inc., 2025) and 1 other predicate after a 32-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Feb 10, 2026
- Review
- 32 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K962616 (1996). 66 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- 2 generations backK170650 Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl · 2017 · Recalled
- 1 generation backK242861 TrueLok ElevateOrthofix Srl · 2024
- This deviceK260073 XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 13 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 12 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 9 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 8 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 7 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 6 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 5 generations backK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- 4 generations backK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- 3 generations backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- 2 generations backK170650 Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl · 2017 · Recalled
- 1 generation backK242861 TrueLok ElevateOrthofix Srl · 2024
- This deviceK260073 XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −14 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −13 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −12 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −9 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −8 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −7 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −6 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| −5 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | — |
| −4 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | — |
| −3 | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | Orthofix Srl | 2015 | — |
| −2 | K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix Srl | 2017 | 1 |
| −1 | K242861 | TrueLok Elevate | Orthofix Srl | 2024 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 K241357 XT3 Systemscore 12.6 · 4 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 |
|---|---|---|---|
| * | K241357 | XT3 SystemSummary page 6…The subject XT3 System has the same intended use and fundamental external fixation principles as the primary predicate XT3 System previously cleared under K241357. The proposed change expands the indications for use to explicitly include treatment of nonunion and correction of bony or soft t… | 2025 |
| * | K242861 | TrueLok ElevateSummary page 5…Predicate Trade Name (Primary Predicate is listed first) Product Code _I K_24_1_35_7___1 _I X_T3_S_y_ste_m_____________l I JDW, KTT I K242861 11 Orthofix Truelok Elevate 11 KTT Device De… | 2024 |
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 30 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 18 of the 66 ancestors have a recall of any class.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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, nonunion and transverse bone transport of the tibia and the correction of bony or soft tissue defects or deformities 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/K260073 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260073: XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260073
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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