# K021071: PCCS Graft Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 1, 2002 after 90 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: 1 generation back to K003286 (2001). 3 ancestors in all.
49 later devices descend from it; 3 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003286: Symphony Graft Delivery System, Depuyacromed (2001)
- K011032: Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone Graft Liquid Applicator (Dual Lumen Cannula, Harvest Technologies, Corp. (2001)
- K012868: Micromedics Fibrijet Aerosol Applicator, Micromedics, Inc. (2001) Summary page 3.

## Most influential descendants
- K072330: Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation System (2007), 47 descendants of its own
- K100754: Graft Delivery System Model SA-6115 (2010), 45 descendants of its own
- K111632: Infill Graft Delivery System (2011), 41 descendants of its own
- K121476: Infill Graft Delivery System (2012), 40 descendants of its own
- K133021: Mixing Syringe System (2014), 32 descendants of its own

## Recalls of this device
- Jun 11, 2007 · Not classified · Z-0993-2007: The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.

## Indications for use
This device is intended for use iflthe delivery of allograft and autograft bone matefials to an orthopedic sttrgical site. In addition, it is designed to facilitate pre-mixing ofbone graft materials with J.V. fluids, blood, plasma, plateiet rich plasma, bone marrow or other specific blood components as deemed necessary by the clinical use requirements.

Source page: https://510kreport.com/device/K021071
Methodology: https://510kreport.com/methodology