510(k) · Cleared

Cleared

A.M. Surgical CPF Distal Radial External Cross Pin Fixation System

K042458510(k) TraditionalCleared Oct 7, 200427-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

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

Cleared on Oct 7, 2004 as substantially equivalent to K020905 (Biomet Orthopedics, Inc., 2002) after a 27-day review. Its family tree reaches back 2 generations to 2000.

Decided: Oct 7, 2004
Review: 27 days
Class: Class II
Product code: LXT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K003240 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK003240 Biomet External Wrist PlateBiomet, Inc. · 2000
1 generation backK020905 NBX - Non-Bridging External FixatorBiomet Orthopedics, Inc. · 2002
This deviceK042458 A.M. Surgical CPF Distal Radial External Cross Pin Fixation SystemA.M. Surgical, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003240	Biomet External Wrist Plate	Biomet, Inc.	2000	—
−1	K020905	NBX - Non-Bridging External Fixator	Biomet Orthopedics, Inc.	2002	—
0 (this device)	K042458	A.M. Surgical CPF Distal Radial External Cross Pin Fixation System	A.M. Surgical, Inc.	2004	—

FIG. 1 — Lineage of K042458, 2000–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K020905	NBX - Non-Bridging External Fixator Summary page 1 …in Fixation System is substantially equivalent in intended use and design to the NBX-Non Bridging External Fixator marketed by Biomet Orthopedics, Inc. under K020905. 4. Device Description: A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is an external wrist…	Biomet Orthopedics, Inc.	2002	—

What descends from it?

No later submission names this one as a predicate yet.

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 4 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
None of the 2 ancestors has a recall.

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

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

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

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

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?

The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is to be used for external stabilization of open and/or unstable fractures of the distal radius were soft tissue injury may preclude the use of other fracture treatments such as IM roding, casting, and other means of external fixation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042458 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042458: A.M. Surgical CPF Distal Radial External Cross Pin Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042458

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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