510(k) · Cleared
ClearedNBX - Non-Bridging External Fixator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Apr 15, 2002 as substantially equivalent to K003240 (Biomet, Inc., 2000) after a 26-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Apr 15, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003240 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003240 Biomet External Wrist PlateBiomet, Inc. · 2000
- This deviceK020905 NBX - Non-Bridging External FixatorBiomet Orthopedics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK042458 A.M. Surgical CPF Distal Radial External Cross Pin Fixation SystemA.M. Surgical, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K042458A.M. Surgical CPF Distal Radial External Cross Pin Fixation SystemA.M. Surgical, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003240 | Biomet External Wrist Plate | Biomet, Inc. | 2000 | — |
| 0 (this device) | K020905 | NBX - Non-Bridging External Fixator | Biomet Orthopedics, Inc. | 2002 | — |
| +1 | K042458 | A.M. Surgical CPF Distal Radial External Cross Pin Fixation System | A.M. Surgical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 LXT? 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 LXT device
- #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K003240 | Biomet External Wrist PlateSummary page 1…nt metallic bone fixation appliances and accessories (21 CFR 888.3030) Legally Marketed Device to which Substantial Equivalence is Claimed: Biomet External Wrist Plate (K003240) Device Description: The device is an external wrist fixator made of radiolucent polymer, polycarbonate. The fixator is a non-br… | 2000 |
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 |
|---|---|---|---|
| K042458 | A.M. Surgical CPF Distal Radial External Cross Pin Fixation System | 2004 | 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?
- Its one ancestor has no recall.
- Of its descendants, K042458 (A.M. Surgical, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LXT devicesLXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LXT
Too few LXT 510(k)s in any year since 2007 to give a median.
Recalls per year · LXT
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXT
7in 2025
MAUDE reports naming product code LXT, 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 | 1 | — | 1 | 26 |
| 2008 | 1 | — | 0 | 58 |
| 2009 | 1 | — | 7 | 41 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 1 | — | 0 | 85 |
| 2012 | 0 | — | 0 | 42 |
| 2013 | 2 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 35 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 66 |
| 2018 | 0 | — | 2 | 73 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Stabilization of open and/or unstable fractures of the distal radius, where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.
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/K020905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020905: NBX - Non-Bridging External Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020905
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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