# K141762: Perfuse Percutaneous Decompression System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 27, 2014 after 57 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003286 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072330: Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System, Biomet, Inc. (2007) Summary page 4.

## Recalls of this device
- Apr 11, 2016 · Class II · Z-1814-2016: The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.

## Indications for use
The PerFuse Percutaneous Decompression System is intended to be used for the delivery of allograft, autograft, and synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate mixing and pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.

Source page: https://510kreport.com/device/K141762
Methodology: https://510kreport.com/methodology