# K090271: Hydrocoat Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Promethean Surgical Devices, Inc.
- Decided: Jan 14, 2010 after 344 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: 9 generations back to K921895 (1992). 43 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980483: Mentor Suspend Sling, Mentor Corp. (1998) Summary page 3.
- K071887: Sportmesh or Artelon Tissue Reinforcement, Artimplant AB (2007) Summary page 3.
- K052830: Sportmesh, Artimplant AB (2006) Summary page 3.
- K041632: Minimesh Polypropylene Mesh, Mpathy Medical Devices, Ltd. (2004) Summary page 3.
- (no number) Ethicon Mersilene Mesh: named in the summary without a submission number

## Most influential descendants
- K093524: Pivit a/B ST and Pivit a/B ST-R (2010), 5 descendants of its own
- K113229: Ventrio Light Hernia Patch with TRM Antimicrobial Coating (2012), 3 descendants of its own
- K133223: Xenmatrix AB Surgical Graft (2014), 2 descendants of its own
- K151177: XenMatrix AB Surgical Graft (2015), 1 descendant of its own
- K211132: ARISTE AB Mesh (2022), 0 descendants of its own

## Indications for use
The HydroCoat Mesh is indicated for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The HydraCoat Mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional hernia, uterovaginal prolapse and other fascial deficiencies that require support material.

Source page: https://510kreport.com/device/K090271
Methodology: https://510kreport.com/methodology