# K142611: TYRX Neuro Absorbable Antibacterial Envelope

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Tyrx, Inc.
- Decided: Dec 31, 2014 after 106 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931386 (1993). 22 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132699: Aigis RX N (Medium), Aigis RX N (Large), Tyrx, Inc. (2013) Summary page 5.
- K130943: Aigis RX R PM/ Aigis RX R Icd, Tyrx, Inc. (2013) Summary page 5.

## Most influential descendants
- K150291: TYRX Neuro Absorbable Antibacterial Envelope (2015), 3 descendants of its own
- K180122: TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) (2018), 1 descendant of its own
- K192636: TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) (2020), 0 descendants of its own
- K152678: TYRX Neuro Antibacterial Envelope (2015), 0 descendants of its own

## Indications for use
TYRXTM Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator or spinal cord neuromodulator securely in order to create a stable environment when implanted in the body. TYRXTM Neuro Absorbable Antibacterial Envelope 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 a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or spinal cord neuromodulators implanted laterally to the body midline and slightly superior to the gluteal region. TYRXTM Neuro Absorbable Antibacterial Envelope is intended for single patient, one-time use only.

Source page: https://510kreport.com/device/K142611
Methodology: https://510kreport.com/methodology