510(k) · Cleared

Cleared

Aneuroplastic, Model 43-1290

K071776510(k) SpecialCleared Jul 26, 200727-day reviewClass II21 CFR 882.5030

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

Codman & Shurtleff, Inc. · JXH Methyl Methacrylate For Aneurysmorrhaphy

Cleared on Jul 26, 2007 as substantially equivalent to K873688 (Dentsply Intl., 1987) and 1 other predicate after a 27-day review. Its family tree reaches back 2 generations to 1997.

Decided: Jul 26, 2007
Review: 27 days
Class: Class II
Product code: JXH
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to P960001 (1997). 5 ancestors in all, the oldest K873688 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backP960001 Depuy 1 Bone CementDepuy, Inc. · 1997
1 generation backK033382 Smartset GMV Endurance Gentamicin Bone CementDePuy Orthopaedics, Inc. · 2004
This deviceK071776 Aneuroplastic, Model 43-1290Codman & Shurtleff, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	P960001	Depuy 1 Bone Cement	Depuy, Inc.	1997	—
−1	K033382	Smartset GMV Endurance Gentamicin Bone Cement	DePuy Orthopaedics, Inc.	2004	—
0 (this device)	K071776	Aneuroplastic, Model 43-1290	Codman & Shurtleff, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
2003	2	0

FIG. 1 — Lineage of K071776, 1997–2007Source: 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 JXH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

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
*	K873688	Aneuroplastic, Acrylic Aneuryomorrhaply Material Summary page 1 …CLASSIFICATION: Class II; 21 CFR 882.5030 DEVICE PRODUCT CODE: JXH SUBSTANTIALLY EQUIVALENT Aneuroplastic" (K873688) DEVICES: SmartSet GMV Endurance Gentamicin Bone Cement…	Dentsply Intl.	1987	—
*	K033382	Smartset GMV Endurance Gentamicin Bone Cement Summary page 1 …Aneuroplastic" (K873688) DEVICES: SmartSet GMV Endurance Gentamicin Bone Cement (K033382) DEVICE DESCRIPTION: Aneuroplastic ~is a self-curing methylmethacrylate (MMA) resin for reinforcing and encapsulating cerebral…	DePuy Orthopaedics, Inc.	2004	—

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 10 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
1 of the 5 ancestors has a recall of any class.

How does its category compare?

All JXH devices

JXH Methyl Methacrylate For Aneurysmorrhaphy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · JXH

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXH

Too few JXH 510(k)s in any year since 2007 to give a median.

Recalls per year · JXH

No recall names JXH since 2007.

Adverse event reports per year · JXH

2in 2022

2007high 2 (2022) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	1
2022	0	—	2
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Aneuroplastic® is indicated for the reinforcing and encapsulating of cerebral aneurysms.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071776 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071776: Aneuroplastic, Model 43-1290.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071776

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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