510(k) · Cleared
ClearedOrthofix External Fixation Screw (Pin) with Hydroxyapatite Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · JDW Pin, Fixation, Threaded
Cleared on Mar 18, 1998 after a 131-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Mar 18, 1998
- Review
- 131 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK974186 Orthofix External Fixation Screw (Pin) with Hydroxyapatite CoatingOrthofix Srl · 1998
- Descendant · cites it directly · 5 of its ownK132820 Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK163487 Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK243798 Orthex External Fixation SystemOrthoPediatrics Corp. · 2025
- Descendant · 2 generations on · 1 of its ownK202054 Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK260900 DYNEX® External Fixation SystemsVilex, LLC · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014 · cites it directly5descendants
- K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017 · 2 generations on4descendants
- K243798Orthex External Fixation SystemOrthoPediatrics Corp. · 2025 · 3 generations on1descendant
- K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020 · 2 generations on1descendant
- K260900DYNEX® External Fixation SystemsVilex, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974186 | Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating | Orthofix Srl | 1998 | — |
| +1 | K132820 | Vilex Ultima External Fixation System with HA Coated Pins and Wires | Vilex, Inc. | 2014 | — |
| +2 | K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | 2017 | — |
| +3 | K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025 | — |
| +2 | K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex, LLC | 2020 | — |
| +3 | K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Orthofix external fixation pin (uncoated) Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132820 | Vilex Ultima External Fixation System with HA Coated Pins and Wires | 2014 | 5 |
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?
- Of its descendants, K132820 (Vilex, Inc., 2014) has gone furthest, with 5 descendants of its own.
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
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 Orthofix external fixation screw (pin) with hydroxyapatite coating is indicated for use in the external fixation of bone.
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/K974186 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974186: Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974186
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