510(k) · Cleared
ClearedVilex Ultima External Fixation System with HA Coated Pins and Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex, Inc. · JDW Pin, Fixation, Threaded
Cleared on Jul 23, 2014 as substantially equivalent to K023921 (Smith & Nephew, Inc., 2003) and 8 other predicates after a 317-day review. Its family tree reaches back 8 generations to 1996. 5 later devices descend from it.
- Decided
- Jul 23, 2014
- Review
- 317 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 8 generations to K962823 (1996). 52 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 7 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 6 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 5 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 4 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 3 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 2 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 1 generation backK112727 Medical Facets Corical Screws, Medical Facets Cancellous Screws…Medical Facets · 2012
- This deviceK132820 Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK163487 Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK243798 Orthex External Fixation SystemOrthoPediatrics Corp. · 2025
- Descendant · cites it directly · 1 of its ownK202054 Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK260900 DYNEX® External Fixation SystemsVilex, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK252625 The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2025
Most influential descendants
Showing 5 of 5 · See all- K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017 · cites it directly4descendants
- K243798Orthex External Fixation SystemOrthoPediatrics Corp. · 2025 · 2 generations on1descendant
- K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020 · cites it directly1descendant
- K260900DYNEX® External Fixation SystemsVilex, LLC · 2026 · 2 generations on0descendants
- K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −7 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −6 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −5 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −4 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −3 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −2 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| −1 | K112727 | Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical… | Medical Facets | 2012 | — |
| 0 (this device) | K132820 | Vilex Ultima External Fixation System with HA Coated Pins and Wires | Vilex, Inc. | 2014 | — |
| +1 | K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | 2017 | — |
| +2 | K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025 | — |
| +1 | K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex, LLC | 2020 | — |
| +2 | K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026 | — |
| +3 | K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (9)
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 |
|---|---|---|---|
| * | K023921 | Jet-X HA Coated Half PinsSummary page 1…040 - Smooth or threaded memntallic bode fastener Product Code: JDW/Orthopedics, Class 11 Predicate Devices: Smith & Nephew Jet-X Half Pins (HA Coated) (K02392 1, K033289) Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating (K97… | 2003 |
| * | K033289 | Modification to Jet-X HA Coated Half PinsSummary page 1…th or threaded memntallic bode fastener Product Code: JDW/Orthopedics, Class 11 Predicate Devices: Smith & Nephew Jet-X Half Pins (HA Coated) (K02392 1, K033289) Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating (K974186) and… | 2004 |
| * | K974186 | Orthofix External Fixation Screw (Pin) with Hydroxyapatite CoatingSummary page 1…ephew Jet-X Half Pins (HA Coated) (K02392 1, K033289) Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating (K974186) and Pins used with Mini Rail System (K955848) Stryker Apex Pins (K06 1493) Wrigh… | 1998 |
| * | K955848 | Orthofix ModulsystemSummary page 1…033289) Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating (K974186) and Pins used with Mini Rail System (K955848) Stryker Apex Pins (K06 1493) Wright Medical Sidekick Rail Half Pins (K080071)… | 1996 |
| * | K061493 | Apex PinsSummary page 1…xation Screw (Pin) with Hydroxyapatite Coating (K974186) and Pins used with Mini Rail System (K955848) Stryker Apex Pins (K06 1493) Wright Medical Sidekick Rail Half Pins (K080071) SBi Mini Rail Half Pins by SBI… | 2006 |
| * | K080071 | Sidekick Rail FixatorSummary page 1…74186) and Pins used with Mini Rail System (K955848) Stryker Apex Pins (K06 1493) Wright Medical Sidekick Rail Half Pins (K080071) SBi Mini Rail Half Pins by SBI (K093550) Treu Kirschner Wires by Treu-lnstrument… | 2008 |
| * | K093550 | Mini Rail External Fixator SystemSummary page 1…Stryker Apex Pins (K06 1493) Wright Medical Sidekick Rail Half Pins (K080071) SBi Mini Rail Half Pins by SBI (K093550) Treu Kirschner Wires by Treu-lnstrumente GMBH (K083912) Medical Facets Kirschner… | 2010 |
| * | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsSummary page 1…Sidekick Rail Half Pins (K080071) SBi Mini Rail Half Pins by SBI (K093550) Treu Kirschner Wires by Treu-lnstrumente GMBH (K083912) Medical Facets Kirschner Wires 13y Medical Facets (KI 12727) Description of Device: This submission inc… | 2009 |
| * | K112727 | Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless… | 2012 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 8 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 52 ancestors have a recall of any class.
- Of its descendants, K163487 (Vilex IN Tennessee, Inc., 2017) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K023921.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Vilex X-Fix is intended for external fixation with the following indications:
1. Stabilization of Fractures & Osteotomy
2. Rear & Mid-toot Foot Arthrodesis
3. Adult and Pediatric Leg Lengthening
4. Correction of Bone Deformity in Upper & Lower Extremities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132820 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132820: Vilex Ultima External Fixation System with HA Coated Pins and Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132820
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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