510(k) · Cleared
Recalled · Class II · 2018Orthofix Modulsystem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · JDW Pin, Fixation, Threaded
Cleared on Mar 20, 1996 as substantially equivalent to K831576 (Electro-Biology, Inc., 1983) after an 84-day review. Its family tree reaches back 1 generation to 1983. 95 later devices descend from it. It has been recalled 23 times.
- Decided
- Mar 20, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- JDW
- Recalls
- 23
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831576 (1983). 95 later devices descend from it, 14 citing it directly.
- Root · 1 generation backK831576 OrthofixElectro-Biology, Inc. · 1983
- This deviceK955848 Orthofix ModulsystemOrthofix, Inc. · 1996
- Descendant · cites it directly · 35 of its ownK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
- Descendant · cites it directly · 32 of its ownK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- Descendant · 2 generations on · 30 of its ownK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 29 of its ownK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 26 of its ownK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
2001high 10 (2014) · low 0 (2002)2026
Most influential descendants
Showing 5 of 95 · See all- K010322Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · cites it directly35descendants
- K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014 · cites it directly32descendants
- K031219Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · 2 generations on30descendants
- K101997Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · 2 generations on29descendants
- K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014 · 2 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| 0 (this device) | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | — |
| +1 | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | 2001 | 1 |
| +1 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | — |
| +2 | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthofix, Inc. | 2003 | 1 |
| +2 | K101997 | Ellipse Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2011 | 2 |
| +2 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 8 | 0 |
| 2026 | 8 | 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? (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 |
|---|---|---|---|
| * | K831576 | OrthofixSummary page 2…bed in this submission have all entered legal distribution in the U.S. as a result of the U.S. Food and Drug Administration’s (FDA’s) clearance of premarket notification K831576. Premarket notification [510(k)] K831576 was submitted to FDA on behalf of Orthofix by Electro-Biology Inc., (EBI), of Parsippany… | 1983 |
What descends from it? (95)
See all 9514 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | 2001 | 35 |
| K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | 2014 | 32 |
| K052196 | Vilex X-Fix | 2005 | 13 |
| K113770 | Orthofix Galaxy Fixation System | 2012 | 6 |
| K132820 | Vilex Ultima External Fixation System with HA Coated Pins and Wires | 2014 | 5 |
| K200518 | Pitkar External Fixation System - Rail Mechanism | 2020 | 2 |
| K241357 | XT3 System | 2025 | 1 |
| K071395 | Biomet Vision Footring System | 2007 | 1 |
| K051017 | R-X-Fix External Fixator | 2005 | 1 |
| K023714 | Reprocessed External Fixation Device | 2003 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2018 | Class II | Z-0373-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0380-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0382-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0383-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0384-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0385-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0386-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0387-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0389-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0390-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0392-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0374-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0375-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0376-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0377-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0378-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0379-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0381-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0388-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0391-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Sep 27, 2018 | Class II | Z-0393-2020 | Device Design | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. |
| Feb 22, 2010 | Not classified | Z-1434-2010 | Nonconforming Material/Component | During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam. |
| Feb 22, 2010 | Not classified | Z-1435-2010 | Nonconforming Material/Component | During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam. |
The 5 latest of 23 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDW
2in 2025
2007high 2 (2007) · low 0 (2008)2026
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
2007high 52 (2012) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
2007high 575 (2019) · low 25 (2007)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?
This product is a unilateral external fixation device, which is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
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/K955848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955848: Orthofix Modulsystem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955848
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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