# K052864: Tyrx Surgical Mesh, Model SMPC-0501

- Pathway: 510(k) (Traditional)
- Applicant: Tyrx Pharma, Inc.
- Decided: Dec 22, 2005 after 72 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: 2 generations back to K001122 (2000). 5 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002672: Vypro Mesh, Vicryl Prolene Partially Absorbable Synthetic Surgical Mesh, ETHICON, Inc. (2000) Summary page 1.
- K962530: Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh, ETHICON, Inc. (1996) Summary page 1.
- K043081: Gore Polypropylene Hernia Mesh, W. L. Gore & Associates, Inc. (2004) Summary page 1.

## Most influential descendants
- K053656: Tyrx Antimicrobial Mesh (2006), 24 descendants of its own
- K063091: Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 (2008), 17 descendants of its own
- 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

## Indications for use
Is intended for the repair of hernias and other abdominal fascial deficiencies requitling the addition of a reinforcing or bridging material to obtain the desired surgical result.. Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.

Source page: https://510kreport.com/device/K052864
Methodology: https://510kreport.com/methodology