510(k) Report

510(k) · Cleared

Cleared

Radiolucent Colles Fracture Kit

K001760510(k) AbbreviatedCleared Aug 31, 200083-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet, Inc. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Cleared on Aug 31, 2000 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Aug 31, 2000
Review
83 days
Class
Class II
Product code
LXT
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared200020052010201520202025
  1. This deviceK001760 Radiolucent Colles Fracture KitBiomet, Inc. · 2000
  2. Descendant · cites it directly · 0 of its ownK021182 Radiolucent Colles Compression/Distraction BarBiomet, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K021182Radiolucent Colles Compression/Distraction BarBiomet, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001760Radiolucent Colles Fracture KitBiomet, Inc.2000—
+1K021182Radiolucent Colles Compression/Distraction BarBiomet, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K001760, 2000–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021182Radiolucent Colles Compression/Distraction BarBiomet, Inc.20020

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, K021182 (Biomet, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LXT devices

LXT 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

2007: 12008: 12009: 12011: 12013: 22023: 1
2007high 2 (2013) · low 0 (2010)2026

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

2007: 12009: 72018: 2
2007high 7 (2009) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LXT

7in 2025

2007: 262008: 582009: 412010: 332011: 852012: 422013: 392014: 362015: 352016: 382017: 662018: 732019: 402020: 322021: 242022: 212023: 182024: 272025: 7
2007high 85 (2011) · low 7 (2025)2025

MAUDE reports naming product code LXT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—126
20081—058
20091—741
20100—033
20111—085
20120—042
20132—039
20140—036
20150—035
20160—038
20170—066
20180—273
20190—040
20200—032
20210—024
20220—021
20231—018
20240—027
20250—07
20260—0—

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in LXT

The LXT category page

  • K230067Para-Fix External Fixation SystemNew Paradigm Biomedical · 2023
  • K131636Polarus ConnectAcumed, LLC · 2013
  • K132704Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate NarrowBiomet · 20131 recall
  • K112345Distal Volar Radius Plating SystemsMedos International SARL · 20114 recalls
  • K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM Threaded and Smooth…DePuy Orthopaedics, Inc. · 2009

https://510kreport.com/device/K001760 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001760: Radiolucent Colles Fracture Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001760

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026