# K063091: Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601

- Pathway: 510(k) (Traditional)
- Applicant: Tyrx Pharma, Inc.
- Decided: Jan 16, 2008 after 463 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931386 (1993). 18 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053656: Tyrx Antimicrobial Mesh, Tyrx Pharma, Inc. (2006) Summary page 1.
- K012198: Gibbons Sterile Trocar Kits, Gibbons Surgical Corp. (2001) Summary page 1.
- (no number) Bard Parsonnet Pacemaker Pouch: named in the summary without a submission number

## Most influential descendants
- K130943: Aigis RX R PM/ Aigis RX R Icd (2013), 14 descendants of its own
- K131007: Aigis RX N Medium; Aigis RX N Large (2013), 6 descendants of its own
- K132699: Aigis RX N (Medium), Aigis RX N (Large) (2013), 5 descendants of its own
- K142611: TYRX Neuro Absorbable Antibacterial Envelope (2014), 4 descendants of its own
- K140306: Cormatrix Protect Ecm Envelope (2014), 4 descendants of its own

## Recalls of this device
- Jun 29, 2016 · Class II · Z-2541-2016: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
- Jun 29, 2016 · Class II · Z-2539-2016: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
- Jun 29, 2016 · Class II · Z-2540-2016: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.

## Indications for use
AIGISRx is intended to securely hold a pacemaker pulse generator or defibrillator in order to create a stable environment when implanted in the body. AIGISRx contains the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection in an in-vivo model of bacterial challenge following surgical implantation of the generator or defibrillator. This device is only intended to be used in conjunction with pacemakers and implantable defibrillators.

Source page: https://510kreport.com/device/K063091
Methodology: https://510kreport.com/methodology