# K071776: Aneuroplastic, Model 43-1290

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Jul 26, 2007 after 27 days
- Product code: JXH (Methyl Methacrylate For Aneurysmorrhaphy)
- Device class: 2
- Regulation: 21 CFR 882.5030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P960001 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873688: Aneuroplastic, Acrylic Aneuryomorrhaply Material, Dentsply Intl. (1987) Summary page 1.
- K033382: Smartset GMV Endurance Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2004) Summary page 1.

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

Source page: https://510kreport.com/device/K071776
Methodology: https://510kreport.com/methodology