# K053424: Popmesh

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: Feb 22, 2006 after 76 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: 1 generation back to K001122 (2000). 2 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh, ETHICON, Inc. (2000)
- K002672: Vypro Mesh, Vicryl Prolene Partially Absorbable Synthetic Surgical Mesh, ETHICON, Inc. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K041362: Resmed Hospital Full Face Mask, Resmed, Ltd. (2004). Our OCR of the scanned summary read K041362, FDA’s number for Resmed Hospital Full Face Mask (Resmed, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Mumesh® Polypropylene Mesh”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K120327: Vertessa (2012), 5 descendants of its own
- K123337: Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM (2013), 1 descendant of its own
- K122440: Restorelle L (2012), 1 descendant of its own
- K070625: Pelvimesh / Hermesh 7 (2007), 1 descendant of its own
- K150016: Vertessa Lite (2015), 0 descendants of its own

## Indications for use
POPmesh™ may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Source page: https://510kreport.com/device/K053424
Methodology: https://510kreport.com/methodology